SILVERTON SFS SET SCREW 5.5MM ROD TI
Report
- Report Number
- 3012447612-2018-00895
- Event Type
- Injury
- Date Received
- November 5, 2018
- Report Date
- May 16, 2022
- Manufacturer
- ZIMMER BIOMET SPINE INC.
- Product Code
- KWP
- PMA / PMN Number
- K100888
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION IN H6: IMPACT AND CLINICAL CODES. VOLUNTARY MEDWATCH MW5108717 WAS RECEIVED FROM FDA AND IS ATTACHED TO THIS REPORT.
IT WAS REPORTED THAT A NON-UNION DEVELOPED POST-OPERATIVELY. THE SPACER WAS DESCRIBED AS BEING CRUSHED, HAS SEVERED TWO NERVE ROOTS, AND HAS AFFECTED THE PATIENT'S BRAIN. THE ROD WAS REPORTED TO BE IMPINGING UPON THE SPINAL CHORD. THERE ARE NO CURRENT PLANS FOR REVISION. THIS IS REPORTED SIX OF SIX FOR THIS EVENT.
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3012447612-2018-00890 THRU 3012447612-2018-00895.
PART NUMBER COULD BE 7703-1500 OR 7703-1600. ADDITIONAL INFORMATION: RESULTS AND CONCLUSIONS - THE DEVICE WAS NOT RETURNED FOR EVALUATION SO NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING PROPER DEVICE USAGE.
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. MDR MW5080740.
IT WAS REPORTED THAT A NONUNION DEVELOPED POST-OPERATIVELY. THE SPACER WAS DESCRIBED AS BEING CRUSHED, HAS SEVERED TWO NERVE ROOTS, AND HAS AFFECTED THE PATIENT'S BRAIN. THE ROD WAS REPORTED TO BE IMPINGING UPON THE SPINAL CHORD. THERE ARE NO CURRENT PLANS FOR REVISION. THIS IS REPORT SIX OF SIX FOR THIS EVENT.
IT WAS REPORTED THAT A NON-UNION DEVELOPED POST-OPERATIVELY. THE SPACER WAS DESCRIBED AS BEING CRUSHED, HAS SEVERED TWO NERVE ROOTS, AND HAS AFFECTED THE PATIENT'S BRAIN. THE ROD WAS REPORTED TO BE IMPINGING UPON THE SPINAL CHORD. THERE ARE NO CURRENT PLANS FOR REVISION. THIS IS REPORTED SIX OF SIX FOR THIS EVENT.
IT WAS REPORTED THAT A NONUNION DEVELOPED POST-OPERATIVELY. THE SPACER WAS DESCRIBED AS BEING CRUSHED, HAS SEVERED TWO NERVE ROOTS, AND HAS AFFECTED THE PATIENT'S BRAIN. THE ROD WAS REPORTED TO BE IMPINGING UPON THE SPINAL CHORD. THERE ARE NO CURRENT PLANS FOR REVISION. THIS IS REPORT SIX OF SIX FOR THIS EVENT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 876597 | SILVERTON SFS SET SCREW 5.5MM ROD TI | MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | KWP | ZIMMER BIOMET SPINE INC. | NA | NI | |
| 876631 | SILVERTON SFS SET SCREW 5.5MM ROD TI | MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | KWP | ZIMMER BIOMET SPINE INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Disability| O |