XIA 3 TITANIUM BLOCKER
Report
- Report Number
- 0009617544-2025-00029
- Event Type
- Injury
- Date Received
- April 3, 2025
- Date of Event
- December 9, 2024
- Report Date
- April 16, 2025
- Manufacturer
- STRYKER SPINE-US
- Product Code
- NKB
- PMA / PMN Number
- K142381
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
WE RECEIVED FOUR POSSIBLE LOT NUMBERS FOR THE DEVICE AND WILL UPDATE THE RECORD IF WE RECEIVE MORE INFORMATION. THE LOT NUMBER COULD BE H78, HJJ, H9N, OR HBM.
CORRECTED DATA: D4, H4.
CORRECTED DATA: D4, H4 ADDITIONAL DATA: H3 H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.
A COMPANY REPRESENTATIVE REPORTED THAT IMAGING TAKEN APPROXIMATELY SIX MONTHS POST-OPERATIVELY REVEALED THAT THREE XIA 3 TITANIUM BLOCKERS MIGRATED. THE PATIENT THEN UNDERWENT REVISION SURGERY APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY. THIS RECORD CAPTURES THE THIRD OF THREE XIA BLOCKERS.
A COMPANY REPRESENTATIVE REPORTED THAT IMAGING TAKEN APPROXIMATELY SIX MONTHS POST-OPERATIVELY REVEALED THAT THREE XIA 3 TITANIUM BLOCKERS MIGRATED. THE PATIENT THEN UNDERWENT REVISION SURGERY APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY. THIS RECORD CAPTURES THE THIRD OF THREE XIA BLOCKERS.
A COMPANY REPRESENTATIVE REPORTED THAT IMAGING TAKEN APPROXIMATELY SIX MONTHS POST-OPERATIVELY REVEALED THAT THREE XIA 3 TITANIUM BLOCKERS MIGRATED. THE PATIENT THEN UNDERWENT REVISION SURGERY APPROXIMATELY EIGHT MONTHS POST-OPERATIVELY. THIS RECORD CAPTURES THE THIRD OF THREE XIA BLOCKERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654765 | XIA 3 TITANIUM BLOCKER | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | STRYKER SPINE-US | H78 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention |