SCREW+SS UNKNOWN SIZE
Report
- Report Number
- 3012447612-2021-00216
- Event Type
- Injury
- Date Received
- June 22, 2021
- Date of Event
- May 25, 2021
- Report Date
- October 22, 2021
- Manufacturer
- ZIMMER BIOMET SPINE INC.
- Product Code
- QHP
- PMA / PMN Number
- H190005
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
D4 EXPIRATION DATE: SEP 30, 2024, DEC 31, 2023, SEP 30, 2024, OR DEC 31, 2023. H4: NOV 8, 2019, DEC 31, 2019, NOV 11, 2019, OR FEB 1, 2019. CORRECTION IN D4: UDI NUMBER: (B)(4). ADDITIONAL INFORMATION IN D4: EXPIRATION DATE, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS WERE NOT PROVIDED, SO A DEVICE EVALUATION COULD NOT BE PERFORMED OUTSIDE OF WHAT WAS DONE VIA X-RAY. MEDICAL RECORDS WERE PROVIDED FOR REVIEW AND SHOW THE OVERCORRECTION AND SPINE AFTER REMOVAL OF THE IMPLANTS. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR OPERATIONAL FACTORS, SURGICAL TECHNIQUE, OR POSTOP EVENTS. DHR REVIEW: PER DHR REVIEW FOR THE SCREWS AND CORD, THESE PARTS WERE LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DHR REVIEW FOR THE ANCHORS COULD NOT BE PERFORMED AS LOT NUMBERS WERE NOT KNOWN. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. 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.
IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RELEASE THE BOTTOM SECTION OF A TETHER CONSTRUCT TO ADDRESS OVERCORRECTION ONE YEAR POST-OPERATIVE. DURING THE REVISION, THE SET SCREWS AND THE CORD WERE REMOVED FROM LEVELS T12 THROUGH L2. NO ADDITIONAL HARDWARE WAS ADDED AND NO FURTHER TREATMENT OUTSIDE OF PATIENT MONITORING IS PLANNED. THIS IS REPORT FOUR OF SEVEN FOR THIS EVENT.
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO RELEASE THE BOTTOM SECTION OF A TETHER CONSTRUCT TO ADDRESS OVERCORRECTION ONE YEAR POST-OPERATIVE. DURING THE REVISION, THE SET SCREWS AND THE CORD WERE REMOVED FROM LEVELS T12 THROUGH L2. NO ADDITIONAL HARDWARE WAS ADDED AND NO FURTHER TREATMENT OUTSIDE OF PATIENT MONITORING IS PLANNED. THIS IS REPORT FOUR OF SEVEN FOR THIS EVENT.
REFERENCE REPORTS 3012447612-2021-00213 TO 3012447612-2021-00219. DEVICE PRODUCT CODE: QHP LOT NUMBER: 3007970, 2970360, 3007972, 2970362, OR 3007969. 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.
IT WAS REPORTED THAT THE BOTTOM OF A CONSTRUCT SHOWED OVERCORRECTION COMPARED TO PREVIOUS IMAGES AT A CHECK UP ONE YEAR POST-OP. IT WAS DECIDED TO RELEASE LOWER CONSTRUCTS. A REVISION SURGERY OCCURRED TO REMOVE INNER CREWS AND TETHER AT LEVELS L1, L2, AND T12. THERE WERE NO NEW IMPLANTS ADDED AT THE TIME OF THE REVISION AND AT THIS POINT, THERE ARE NO FURTHER TREATMENT PLANS OUTSIDE CONTINUED OBSERVATION.THIS IS REPORT FOUR OF SEVEN FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 942252 | SCREW+SS UNKNOWN SIZE | THE TETHER - VERTEBRAL BODY TETHERING SYSTEM | QHP | ZIMMER BIOMET SPINE INC. | N/A | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |