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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I’m in the spine business and wanted to share this information with you. Robots in spine today are for marketing purposes only. The data suggests that robotic assisted spine surgery is the least safe way to put in a pedicle screw. Good luck with your recovery and God bless.

In Spine with experience with Mazor and I would second this. Amazing the risk and responsibility the entry level reps (sometimes kids straight from college) have placed on them. They sit in the hospital planning the surgery for the surgeons just bf the surgery. Plus so much more critical and risky responsibilities.

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I’m in the spine business and wanted to share this information with you. Robots in spine today are for marketing purposes only. The data suggests that robotic assisted spine surgery is the least safe way to put in a pedicle screw. Good luck with your recovery and God bless.

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Who was the Mazor Rep and Manager during your surgery?

Look it up on LinkedIn. Aaron Barnette is the manager

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We all have stories to be told to help patient quality or save a life.

Here is a site for discussing issues in medical. Created by people actually in medical. 100% anonymity.

Give your input as we form its content accordingly. Add input in “General Discussion” page.

https://www.insidemedtalk.com/


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The agency [FDA] announced on Friday it has made publicly available approximately 6 million adverse event reports dating back to 1999 that were previously not included in the federal database Manufacturer and User Facility Device Experience, or MAUDE. Those reports previously were exempted under the FDA's Alternative Summary Reporting program.

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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.

“Shocking new”?!?

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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.

Advice or a threat from a Mazor Manager?

Show Language

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This surgeon is one of their early adopters so most experienced Sr Surgeon. I have heard of reps leaving due to the Mazor culture and clinical risks and responsibilities they’re under. Risks that should be under the Surgeon and staff but fall under them or end up falling under them. Would you want a 25 year old rep placing your Mother’s screws? That same rep focused on multiple points which of missed could paralyze or kill the patient? Some with zero spine experience coming in and some with zero clinical OR experience. Now cashing their stock after Medtronic purchased them.

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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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