Mazor Robotics Adverse Events with Renaissance

I was severely injured by a surgeon using the Mazor Renaissance System. I would be interested in hearing from anyone else on this post that has there lives turned upside down by them.

I had 18 screws put in with multiple badly misaligned, two of them within my spinal canal. All the screws were removed prematurely at five months, leaving me with multiple levels with a nonunion and no hardware, causing my entire lumbar to be destroyed with screw tracts ruined, coronal planes ruined, PI vs Lordosis significant and flat back on top the nerve injury.

The pain is excruciating, simply disabling torture. Think of having 18 screws put into your back and removed with nothing to hold it in place.

The surgeon who did this to me actually promoted for purchase the system to the hospital I was injured at. He does YouTube videos for them and teaches and promotes the system. I found out that despite the 98.3% guidance accuracy they advertise, that inn my case the surgeon did not even report the incident, which has devastated my life and that of my wife. Had to have three major open spine back surgeries, two months ago in an effort to fix some of the damage and will need at least one more.

Eleven days in the hospital, every day now in bed laying on clay ice pads, the wife is heartbroken, I am devastated. The surgeon has a vested interest in not reporting incidents or errors. In the coming weeks I hope to bring out the full story of Mazor appealing actions following being told of this. Patient safety is referred to risk management. I want to speak with Medtronic before posting more to see if the culture has changed. Mazor ruined my life.

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How were the screws misplaced?

-Rep plans screw placement on software with Surgeon’s approval. Very Critical step if done wrong

-Reps Register The System in the OR. Very Critical step if done wrong

-Rep ensures or watches to make sure proper mount is used and properly stewed into back. Very Critical step if done wrong

-Rep calls out mount location for robot, side (right/left), and short/long instruments making sure all instruments are used properly all without being in the sterile field. Very Critical step if done wrong

-Rep ensures that all steps are done and that there is no skiving off the bone or tissue. Very Critical step if done wrong

This is just a basic case (some can present greater challenges) and people have NO IDEA how critical and challenging it is for the reps/managers taking these risky clinical responsibilities. Add to that in many cases they have hired reps with little to no sales experience, OR (or medical) exp., or spine exp. It’s an entry level job with (very) Jr Reps and (very) Jr Mngrs.

Thank you, very interesting post. I have no idea how the screws ended up so badly misplaced, only that they all needed to be removed, and that it has left my spine in shambles. They will not provide me the medical records related to the robotics. I have recently found out some shocking news regarding this incident, but not sure if I want to post, although the site is greatly appreciated.

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Here is one example of a second opinion following the Mazor screw misalignments I am not putting the name of the surgeon here for privacy but have the original reports for the FDA or Medtronic. Dr. "" a neurosurgeon with "" of Tampa, who is one of the neurosurgeons we sought out for a second opinion.

In part he wrote within his assessment of my injuries on 05/31/2018, quote “The majority of his pain is related to his back at this point and appears to be axial and mechanical in nature. I feel this is likely related to no significant fusion development following his prior(procedures).” (Plural)

“He did undergo a T 10–ilium fusion which did help with his back pain, but due to misplaced hardware it appears his surgeon removed his hardware at five months post-op which was not enough time for adequate fusion formation most likely, however this appears to have been an attempt to alleviate nerve compression.” as a result of the screw misplacement,

“There is no guarantee that this will help with his pain. He understands the high risk given prior misplaced screws and possible degradation of his pedicle tracts.”

Would recommend T7–ilium PSIF/posterolateral fusion to treat his axial mechanical back pain from likely instability.”

The above second opinion is only one for five we have. This surgery would be an eleven level open spine fusion to fix this Mazor error. Dr. Sweeney gets away with his YouTube videos and promoting a 98.3% accuracy level while not reporting errors. He has a testimonial on the Mazor website that directly contradicts himself,. He sold the robotics to the hospital where he is not reporting errors, which can be found on Google. Simply despicable

How were the screws misplaced?

-Rep plans screw placement on software with Surgeon’s approval. Very Critical step if done wrong

-Reps Register The System in the OR. Very Critical step if done wrong

-Rep ensures or watches to make sure proper mount is used and properly stewed into back. Very Critical step if done wrong

-Rep calls out mount location for robot, side (right/left), and short/long instruments making sure all instruments are used properly all without being in the sterile field. Very Critical step if done wrong

-Rep ensures that all steps are done and that there is no skiving off the bone or tissue. Very Critical step if done wrong

This is just a basic case (some can present greater challenges) and people have NO IDEA how critical and challenging it is for the reps/managers taking these risky clinical responsibilities. Add to that in many cases they have hired reps with little to no sales experience, OR (or medical) exp., or spine exp. It’s an entry level job with (very) Jr Reps and (very) Jr Mngrs.

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It's up to the rep to take the initiative to file a report so don't count on anything changing because it is rep specific.

As to this case, could the surgeon just be bad? Or maybe he lacked adequate training? I've seen this with other devices where the company who manufacturers the device ends up taking the fall. Remember, the device has to be operated by someone.

It is up to the rep to plan the spine or brain case and therefore placement of each screw or tome. The doc usually spends a few minutes just before the case to quickly review through the software on the rep’s laptop. The surgeon is really supposed to have the software on their laptop to fully plan the procedure themselves start to finish. It’s also up to the rep to run multiple very critical aspects of the set up, I intra-operative registration and pedicle screw placement part of the case. Responsible for running the case without one error which could be critical for the doc and patient. The reps are also responsible for watching for certain critical errors like skiving or the use long vs short tool among other things.

This is a serious challenge for Mazor and their Renaissance system IMO and others. Many of the Mazor reps have little to no experience in medical, OR, Spine or Robotics before being hired with some being promoted to manager. Execs were able to make an exit plan and sell to Medtronic finally for a low price. Wonder why they sold it for so low? So much can go critically wrong IMO

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Not sure why that matters? The rep was likely a clinical and they are not going to override anything a surgeon says or is doing. They are required to report any adverse events to the company which are then reported to the MAUDE database. As most of us know, many times they're not reported. I would bet now that Medtronic is in charge, more adverse events will be reported but many times small companies (which mazor was) don't do a good job of making their reps fill out adverse events when they happen. Therefore, products that break or malfunction during cases end up in the trash instead of being sent back to the company for review.

It's up to the rep to take the initiative to file a report so don't count on anything changing because it is rep specific.

As to this case, could the surgeon just be bad? Or maybe he lacked adequate training? I've seen this with other devices where the company who manufacturers the device ends up taking the fall. Remember, the device has to be operated by someone.

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Who was the Mazor Rep and Manager during your surgery?

Not sure why that matters? The rep was likely a clinical and they are not going to override anything a surgeon says or is doing. They are required to report any adverse events to the company which are then reported to the MAUDE database. As most of us know, many times they're not reported. I would bet now that Medtronic is in charge, more adverse events will be reported but many times small companies (which mazor was) don't do a good job of making their reps fill out adverse events when they happen. Therefore, products that break or malfunction during cases end up in the trash instead of being sent back to the company for review.

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The surgeon was Thomas Sweeney at Doctors Hospital, Sarasota. Florida

You're posts mean the world to me, anonymous feels real. I am going to contact Medtronic later this week. I am in terrible pain and am dealing with that, which sounds lame but it is excruciating. I will be posting additional information within the coming days, but having a hard time right now.

Thank you so much for the information, I will be checking it all out. Will definitely keep it real, unfortunately, the truth is a real bummer, and needs to be told. Please feel free to reach out again if you have anything else that might help. Your posting has brought my spirits up considerably.

Glad this is encouraging and sorry to hear about your situation.

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MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. RENAISSANCE STEREOTACTIC DEVICE

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=7914217&pc=HAW

It is the Mazor/MDT Rep’s responsibility to call out the position, direct the robot and surgeon to its placement.

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Who was the Mazor Rep and Manager during your surgery?

that will probably come out in the discovery phase.

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Who was the Mazor Rep and Manager during your surgery?

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There is nothing on this thread that could get this person in trouble. I do agree though that a lawyer would help them get some compensation for dealing with this experience.

The “Dude” poster could be Mazor discouraging your post possibly.

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Dude, you need to get off the internet and get yourself a lawyer. You don't want something you post here to bite you in the *** and add insult to injury.

There is nothing on this thread that could get this person in trouble. I do agree though that a lawyer would help them get some compensation for dealing with this experience.

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Here is one example of a second opinion following the Mazor screw misalignments I am not putting the name of the surgeon here for privacy but have the original reports for the FDA or Medtronic. Dr. XXXX XXXXXXX a neurosurgeon with XXXXXXX XXX of Tampa, who is one of the neurosurgeons we sought out for a second opinion.

In part he wrote within his assessment of my injuries on 05/31/2018, quote “The majority of his pain is related to his back at this point and appears to be axial and mechanical in nature. I feel this is likely related to no significant fusion development following his prior(procedures).” (Plural)

“He did undergo a T 10–ilium fusion which did help with his back pain, but due to misplaced hardware it appears his surgeon removed his hardware at five months post-op which was not enough time for adequate fusion formation most likely, however this appears to have been an attempt to alleviate nerve compression.” as a result of the screw misplacement,

“There is no guarantee that this will help with his pain. He understands the high risk given prior misplaced screws and possible degradation of his pedicle tracts.”

Would recommend T7–ilium PSIF/posterolateral fusion to treat his axial mechanical back pain from likely instability.”

The above second opinion is only one for five we have. This surgery would be an eleven level open spine fusion to fix this Mazor error. Dr. Sweeney gets away with his YouTube videos and promoting a 98.3% accuracy level while not reporting errors. He has a testimonial on the Mazor website that directly contradicts himself,. He sold the robotics to the hospital where he is not reporting errors, which can be found on Google. Simply despicable

Dude, you need to get off the internet and get yourself a lawyer. You don't want something you post here to bite you in the *** and add insult to injury.

Show Language

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What has Dr. Sweeney said to you about these adverse events?

Here is one example of a second opinion following the Mazor screw misalignments I am not putting the name of the surgeon here for privacy but have the original reports for the FDA or Medtronic. Dr. "" a neurosurgeon with "" of Tampa, who is one of the neurosurgeons we sought out for a second opinion.

In part he wrote within his assessment of my injuries on 05/31/2018, quote “The majority of his pain is related to his back at this point and appears to be axial and mechanical in nature. I feel this is likely related to no significant fusion development following his prior(procedures).” (Plural)

“He did undergo a T 10–ilium fusion which did help with his back pain, but due to misplaced hardware it appears his surgeon removed his hardware at five months post-op which was not enough time for adequate fusion formation most likely, however this appears to have been an attempt to alleviate nerve compression.” as a result of the screw misplacement,

“There is no guarantee that this will help with his pain. He understands the high risk given prior misplaced screws and possible degradation of his pedicle tracts.”

Would recommend T7–ilium PSIF/posterolateral fusion to treat his axial mechanical back pain from likely instability.”

The above second opinion is only one for five we have. This surgery would be an eleven level open spine fusion to fix this Mazor error. Dr. Sweeney gets away with his YouTube videos and promoting a 98.3% accuracy level while not reporting errors. He has a testimonial on the Mazor website that directly contradicts himself,. He sold the robotics to the hospital where he is not reporting errors, which can be found on Google. Simply despicable

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What has Dr. Sweeney said to you about these adverse events?

Thank you for asking what Dr. Sweeney has done about this, The problem has been with Dr. Sweeney. If you read below this posting where it begins with December 31, you can read what I posted on Facebook this past December out of desperation. It was on a Mazor Facebook page regarding robotics successes.

It goes into some of the details but what I have found out since is a whole new story of deceit. The bad and good news is that Mazor first than Medtronic read this posting and contacted me, but it appears it is Risk Management again, under the guise of Patient Safety, as my posting below explains what happened previously. I had reached out multiple times privately and they ignored me, so I tried FaceBook and now this website, which is fantastic for public safety.

I am going to speak with them later this month, but it feels like an effort to keep these errors under wraps. We were not even informed of the spinal canal screw encroachment and other misalignments by our surgeon but instead found out by an emergency room doctor. I was having trouble breathing, swallowing, terrible pain wrapping around my chest, etcetera just days after leaving the hospital. We found out Sweeney

was filing erroneous medical records that I hope to post here if things don’t work out with Medtronic’s patient safety folks. It is a continuing nightmare.

I have several second opinion Neurosurgeon reports regarding the multiple misplaced screws and the significant damage done to my spine that I want to post here as well. In my opinion it is 100% unethical was Dr. Sweeney has done to me and others. I also hope to post what he has done to others that are available in public records, but you need Lexis Nexis, which I don’t have, but was provided to me by a friend, that show his manipulation of patents and their health records within litigation.

Your interest gives me hope and helps while recovering from the three open spine surgeries in December that were caused by this negligence. The nerve pain from the screw misalignments cannot be resolved and it is simply maddening.

December 31, 2018
Mazor, Medtronic Medical Device & Management Alert
I was seriously injured by a surgeon at Doctors Hospital of Sarasota, Florida using the Mazor Renaissance Robotics System. This surgeon Dr. Thomas M. Sweeney, was instrumental in selling the Renaissance system to Doctors Hospital, is featured in a YouTube video promoting the accuracy of the robotics for Mazor and is on the main Mazor website promoting the accuracy. He was also featured In the Tampa Bay Medical newspaper in December 2013 regarding Doctors Hospital purchasing the system and consistency and accuracy of the system. This surgeon, Mazor and Medtronic management and others have a vested interest in not disclosing injuries to investors, hospitals, patients, while creating a false or fraudulent accuracy level which they tout at 98.3% plus, which they know is simply false and certainly misleading.

In my case, out of 18 screws placed in my thoracic through pelvis, two were within the spinal canal, one abutting my spinal cord and multiple others seriously misaligned. Because of issues related to my having difficulty with swallowing, catching a breath and pain reaching around my chest the surgeon prematurely removed all 18 screws and two 12” rods, instead of just the offending screws after only five months, leaving me in excruciating pain with no hardware, no fusion and a mutilated back, along with a false narrative by the surgeon. I found out after this injury, that this surgeon probably others are not reporting errors to hospitals, FDA, etcetera. It turns out this surgeon Dr. Thomas M. Sweeney who is a Mazor spokesman also has had four malpractice lawsuits filed against him, significantly higher than the national average. One of the malpractice lawsuits involved another device (Coflex in the lumbar not FDA approved) which the surgeon also promoted on YouTube, with similar misleading research and documented mischievous and manipulative medical notes and records.

I was subsequently told by multiple surgeons that Mazor Robotics has a "slippage" issue amongst other problems, causing serious accuracy issues when these injuries are not being reported. Mazor and Medtronic management is not interested in facts regarding accuracy, especially while in the midst of currently pulling the wool over investors eyes.

Importantly, I was contacted by a Mazor representative, Yoel Ben-Artzi, Mazor Senior Director Global Services who is also known as Joel aka Jorge Mario Inwentarz. Yoel or Joel or Jorge contacted me asking for contact and other information with promises of getting to the bottom of this injury. This is a story in itself that will come out but does speak to the integrity of Mazor and its Senior Global representatives. When I provided Jorge proof with pictures of the spinal cord encroachment and other information, and the name of the Mazor surgeon representative that promotes the system, he cut off all contact.

Medtronic and Mazor have since refused to review my injuries once they understood I was accurate after telling them the facts and the name of the important spokesman surgeon who operated on me.

You would hope they would be interested in reality when it involves patient safety.

Apparently, these Medtronic/Mazor representative are hoping my injuries and probably others will go away, based on the dishonesty they have shown in my case, especially during the $1.6 billion acquisition of Mazor scheduled to finalize in late January 2019.

Medtronic just bought an overpriced house of cards and they know it but will never let the truth come out regarding the misleading accuracy levels. This dishonesty has devastated my wife and me, when we relied on this Renaissance System information to be accurate. They will not allow investors to know the truth, hospitals would be reluctant to purchase these systems knowing that one untruth or misleading facts of accuracy and injury, especially when not reported can lead to others. I have attempted to reconnect with both companies and am ignored, but the disabling excruciating painful injuries to myself and the mental anguish of my wife having to go through this will not allow this to just go away. The deception by a Mazor representative is appalling, the dishonesty to my family, shows the true odd character and reality of these companies.

The true accuracy rate of the Renaissance System and possibly other systems is built on deception.
These are despicable companies that will attempt to roll over families like my own with no interest in the reality of accuracy involving these expensive systems. Patients are disposable when huge amounts of dollars rule the day for.

Importantly they flagrantly lied to my family about getting to the bottom of this at a time when we were both polite and helpful. They contacted me to lay the groundwork to deceive us, not find out about the injuries not being reported by surgeons with a vested interest in only positive reporting.
If they show this open dishonesty, what does that say about the true character and integrity of their systems when senior staff acts like this, God only knows the truth of these flawed systems?
I was also contacted by Mazor Clinical Sales representative Brandon Shimko who asked me how he could help, until he knew my story of injury from their system. So much for honesty in Clinical Sales at Mazor/Medtronic, which should worry all patients, hospitals, liability companies, investors etcetera.

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