FDA Adverse Event
Malfunction
Summary report: N
XIA SERRATO 8.5X50 POLYAXIAL SCREW
MDR report key: 24879548
·
Received April 14, 2026
Report
- Report Number
- 0009617544-2026-00071
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- April 2, 2026
- Report Date
- April 14, 2026
- Manufacturer
- STRYKER SPINE-US
- Product Code
- NKB
- UDI-DI
- 07613327352344
- PMA / PMN Number
- K170496
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A COMPANY REPRESENTATIVE REPORTED THAT THE TULIP OF A XIA SERRATO POLYAXIAL SCREW DISENGAGED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. A REVIEW OF PRODUCT HISTORY INDICATES THERE HAVE BEEN REPORTS OF DEATH OR SERIOUS INJURY RESULTING FROM SIMILAR EVENTS WITH THIS DEVICE. THEREFORE, THIS EVENT WILL BE REPORTABLE TO THE FDA AS A MALFUNCTION. THIS RECORD HAS BEEN ASSESSED PER QSD-1265 FOR NECESSITY OF COUNTRY ASSESSMENT RECORDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938033 | XIA SERRATO 8.5X50 POLYAXIAL SCREW | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | STRYKER SPINE-US | 252821 | 07613327352344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |