MAUDE Adverse Event Report: MEDTRONIC PEEK CAGE - LEGACY SCREWS; PEEK CAGE LEGACY SCREWS

Device Problem Collapse (1099)

Patient Problem No Information (3190)

Event Date 05/14/2014

Event Type  Injury  

Event Description

I had a pars fracture on my 15-s1.The surgery took place at (b)(6).Product that was placed in me was a medtronic legacy screws, with impacted local bone and allograft bone across the screws and rods, medtronic keystone cage.The fusion didn't take and at 15 was deteriorating.Per the revision surgery they did an anterior l5-s1 discectomy with removal of the prior l5-s1 inter body.Anterior l5-s1 arthrodesis instrumentation using peek inter body cage x1 packed with infuse (small), supplemental with screws x 2, anterior lumbosacral plate x1, and screws x4.Dr.(b)(6) who fixed the non union surgery wrote that the disk was collapsed down and we had to use increase in size of distractor to give a space for further discectomy.In the disk space, he did not visualize the implant.With drilling portions of the l5 enplane to the left side, he finally visualized the peek implant that had been placed previously.The implant was mostly in the l% vertebral body.He carefully dissolved the implant and moved it.He then continued with the aggressive discectomy.I don't know how it happened.Did the first doctor do anything correct.All of his paperwork is incorrect.It is hard to explain this in writing.I would like to send you all the back up i have.The first doctor told me i will never be the same and that there is nothing he can do but operate.I would never let him operate on me again.

• Brand Name: PEEK CAGE - LEGACY SCREWS
• Type of Device: PEEK CAGE LEGACY SCREWS
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5466455
• MDR Text Key: 39346365
• Report Number: MW5060568
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 48 YR
• Patient Weight: 64