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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Looks like a cafepharma for Reps vent about the docs. Glad to inform patients and help a few people. Some crazy stories.

There’s almost no content there. Don’t waste your time.

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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/


Looks like a cafepharma for Reps vent about the docs. Glad to inform patients and help a few people. Some crazy stories.

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If you look up on Maude, a majority of the MDR's are due to placement imprecision...Rep's fault, device's fault or surgeon's fault??

Model Number TPL0059
Device Problem Imprecision
Event Date 05/30/2019
Event Type Injury
Manufacturer Narrative

Device evaluated by mfr: software exports were returned, however analysis was not yet completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a guidance device being used in a spinal procedure. It was reported that the plan for the case was to perform a scan and plan and execute screws at t11, t12, l2, and l3. This was to back up a l1 burst fracture. Once the surgeon exposed the region of interest, the rep suggested using the dual clamp and clamping at t12 and l2 spinous processes. This was to avoid the instability of l1. The dual clamp was placed, 3define performed, snapshot taken and then star marker placed. Due to the size of the patient and height of the dual clamp, it took three spins of the o-arm to achieve registration. Screws were then planned and reviewed with the surgeon.

Thoracic screws were planned between 8-10 degrees off midline to account for any soft tissue problems, with lumbar screws planned slightly more lateral. The rep noted the small pedicles to the surgeon and asked if they would like to adjust to 4. 5mm screws and they opted to keep them at 5. 5mm. The screws were then executed starting with t11 on the right and working down, followed by t11 on the left and working down. Navigation showed all trajectories to be accurate to plan and surgeon was very pleased with how the case was progressing. It was noted that neither rep noticed any soft tissue pressure on any trajectory, and the surgeon was well aware to watch out for this as well. Once all screws were in place however, the surgeon noted that t12 on the right appeared to be slightly medial to corresponding tulip heads. The rep requested that the surgeon take an ap image to confirm that the screw was in fact medial. Imaging showed the screw was in fact medial to plan and pedicle. The surgeon then pulled the screw and informed the reps that the screw had breached the canal.

They then took the passive planar inside the screw hole and this also showed a medial deviation. The surgeon told the reps to remove the robot from the room as they called another physician to devise a plan. The surgeon then had the o-arm come back in for another spin to proceed with the case. After the spin, the rep scrolled through the images on the o-arm outside the room to confirm all other screws were accurate. Every single screw was100% accurate to plan except for the screw hole at t12 right, which was medial by roughly 5mm and the screw at t12 left, which was slightly lateral to plan but acceptable. The rep went on to perform a 10 point accuracy test, and shoulder calibration test to be sure all was well with the robot and passed both. The spine rep informed the rep that there was a slight dural leak and they believed it occurred during the screw placement and not the 3. 0 drill or 4. 5mm tap. The rep later informed the reporter that surgeon believed they had repaired the leak. It was also noted that during initial drilling of right l2, the black nav lock and long drill appeared to become "fused" somehow.

The rep thought that it was due to bone density at this level the nav lock became torqued and thus resulted in the drill and nav lock becoming locked together. The surgeon was unable to disengage the black nav lock from the drill regardless of force applied. At this point the rep had an hcp attach a back up long drill with the blue nav lock. The blue nav lock was then switched between long drill and long tap accordingly. The power ease rpms were continually adjusted between 250rpm for the drill and 150rpm for tap and driver. It was noted that changes to the course of the surgery included the removal of the right t12 screw, fixing the dural tear and reinserting the screw freehand.

The procedure was delayed for over an hour. It was reported that they had issues with the black nav lock ¿fusing¿ to the long drill guide. It was noted that the surgeon worked on the right side of the patient for the entire procedure. However it was also noted that they believed the surgeon switched sides. The surgeon technique was well within protocol with them malleting lightly, followed by a heavier malleting. There was no bone removal prior to the trajectories. The screws were off by approximately 5 mm. There were no additional complications reported or anticipated as a result of the event.

Sounds like Mason...lived by the sword and will die by it.

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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.

If you look up on Maude, a majority of the MDR's are due to placement imprecision...Rep's fault, device's fault or surgeon's fault??

Model Number TPL0059
Device Problem Imprecision
Event Date 05/30/2019
Event Type Injury
Manufacturer Narrative

Device evaluated by mfr: software exports were returned, however analysis was not yet completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a guidance device being used in a spinal procedure. It was reported that the plan for the case was to perform a scan and plan and execute screws at t11, t12, l2, and l3. This was to back up a l1 burst fracture. Once the surgeon exposed the region of interest, the rep suggested using the dual clamp and clamping at t12 and l2 spinous processes. This was to avoid the instability of l1. The dual clamp was placed, 3define performed, snapshot taken and then star marker placed. Due to the size of the patient and height of the dual clamp, it took three spins of the o-arm to achieve registration. Screws were then planned and reviewed with the surgeon.

Thoracic screws were planned between 8-10 degrees off midline to account for any soft tissue problems, with lumbar screws planned slightly more lateral. The rep noted the small pedicles to the surgeon and asked if they would like to adjust to 4. 5mm screws and they opted to keep them at 5. 5mm. The screws were then executed starting with t11 on the right and working down, followed by t11 on the left and working down. Navigation showed all trajectories to be accurate to plan and surgeon was very pleased with how the case was progressing. It was noted that neither rep noticed any soft tissue pressure on any trajectory, and the surgeon was well aware to watch out for this as well. Once all screws were in place however, the surgeon noted that t12 on the right appeared to be slightly medial to corresponding tulip heads. The rep requested that the surgeon take an ap image to confirm that the screw was in fact medial. Imaging showed the screw was in fact medial to plan and pedicle. The surgeon then pulled the screw and informed the reps that the screw had breached the canal.

They then took the passive planar inside the screw hole and this also showed a medial deviation. The surgeon told the reps to remove the robot from the room as they called another physician to devise a plan. The surgeon then had the o-arm come back in for another spin to proceed with the case. After the spin, the rep scrolled through the images on the o-arm outside the room to confirm all other screws were accurate. Every single screw was100% accurate to plan except for the screw hole at t12 right, which was medial by roughly 5mm and the screw at t12 left, which was slightly lateral to plan but acceptable. The rep went on to perform a 10 point accuracy test, and shoulder calibration test to be sure all was well with the robot and passed both. The spine rep informed the rep that there was a slight dural leak and they believed it occurred during the screw placement and not the 3. 0 drill or 4. 5mm tap. The rep later informed the reporter that surgeon believed they had repaired the leak. It was also noted that during initial drilling of right l2, the black nav lock and long drill appeared to become "fused" somehow.

The rep thought that it was due to bone density at this level the nav lock became torqued and thus resulted in the drill and nav lock becoming locked together. The surgeon was unable to disengage the black nav lock from the drill regardless of force applied. At this point the rep had an hcp attach a back up long drill with the blue nav lock. The blue nav lock was then switched between long drill and long tap accordingly. The power ease rpms were continually adjusted between 250rpm for the drill and 150rpm for tap and driver. It was noted that changes to the course of the surgery included the removal of the right t12 screw, fixing the dural tear and reinserting the screw freehand.

The procedure was delayed for over an hour. It was reported that they had issues with the black nav lock ¿fusing¿ to the long drill guide. It was noted that the surgeon worked on the right side of the patient for the entire procedure. However it was also noted that they believed the surgeon switched sides. The surgeon technique was well within protocol with them malleting lightly, followed by a heavier malleting. There was no bone removal prior to the trajectories. The screws were off by approximately 5 mm. There were no additional complications reported or anticipated as a result of the event.

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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.

Has anyone read through these issues? Just click on every link under the Brand Name section

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm

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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.

post

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.

post

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/


post

This post has images that are pending moderation in accordance with our removal policy.

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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