FDA Adverse Event
Injury
Summary report: N
XIA LP POLYAXIAL SCREW 6.5 X 40MM
MDR report key: 1163113
·
Received September 16, 2008
Report
- Report Number
- 9617544-2008-00096
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- July 22, 2008
- Report Date
- August 20, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT OF ADDITIONAL INFO AND EVALUATION, A SUPPLEMENTAL WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS STATED THAT "PATIENT WENT INTO DOCTOR'S OFFICE FOR FOLLOW UP VISIT AND X-RAYS AND IT SHOWED THE HEAD OF THE SCREW POPPED OFF THE SHAFT. DOCTOR SCHEDULED REVISION SURGERY IMMEDIATELY AND REPLACED THE OLD SCREW WITH A NEW MONO AXIAL STYLE SCREW. OUT COME WAS VERY GOOD."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA LP POLYAXIAL SCREW 6.5 X 40MM | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other |