FDA Adverse Event
Malfunction
Summary report: N
XIA LP POLYAXIAL SCREW 6.5 X 45MM
MDR report key: 1041352
·
Received May 6, 2008
Report
- Report Number
- 9617544-2008-00036
- Event Type
- Malfunction
- Date Received
- May 6, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 11, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K060361
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE IS LIMITED INFORMATION AT THIS TIME. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND IF RECEIVED WILL BE SUPPLIED ON A SUPPLEMENTAL. CAT # 03821650, XIA LP POLYAXIAL SCREW 6.5 X 50 MM HAS ALSO BEEN REFERENCED BUT IT IS UNKNOWN, WHICH, IF ANY, OF THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE IMPLANT BEING SUBJECT TO PER FRACTURED DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA LP POLYAXIAL SCREW 6.5 X 45MM | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | A72204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |