POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
Report
- Report Number
- 3012447612-2025-00229
- Event Type
- Injury
- Date Received
- May 28, 2025
- Report Date
- September 17, 2025
- Manufacturer
- ZIMMER BIOMET SPINE, INC.
- Product Code
- NKB
- PMA / PMN Number
- SEEH10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4: THE UDI NUMBER IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS ARE NOT AVAILABLE. G4: PMA/510(K) #: K141804 OR K061441. 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 3012447612-2025-00228 THROUGH 3012447612-2025-00231.
ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS SUCH AS DEGRADING BONE QUALITY OVER TIME, STRESS SHIELDING OF THE BONE OVER TIME, USING AN INCORRECTLY SIZED OR ALIGNED TAP, OR MISALIGNMENT OF THE SCREW THREADS IN THE TAP PATHWAY. DHR REVIEW: THE LOT NUMBER WAS NOT REPORTED AND THE DEVICE WAS NOT RETURNED, THEREFORE A DHR REVIEW IS UNABLE TO BE PERFORMED. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. 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 ADDRESS LOOSENING OF THREE POLARIS SCREWS IN THE BONE. IT WAS ALSO REPORTED THAT ONE FRACTURED POLARIS SCREW WAS REMOVED. THE 6.5 DIAMETER SCREWS WERE REMOVED AND REPLACED WITH LARGER 9.5 DIAMETER SCREWS, AND THERE WAS NO REPORTED PATIENT IMPACT BEYOND THE REVISION. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS LOOSENING OF THREE POLARIS SCREWS IN THE BONE. IT WAS ALSO REPORTED THAT ONE FRACTURED POLARIS SCREW WAS REMOVED. THE 6.5 DIAMETER SCREWS WERE REMOVED AND REPLACED WITH LARGER 9.5 DIAMETER SCREWS, AND THERE WAS NO REPORTED PATIENT IMPACT BEYOND THE REVISION. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 990419 | POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | ZIMMER BIOMET SPINE, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |