FDA Adverse Event
Malfunction
Summary report: N
LAG SCREW, T1 10.5X90MM
MDR report key: 1071838
·
Received July 8, 2008
Report
- Report Number
- 9610622-2008-00112
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- June 10, 2008
- Report Date
- June 16, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE SURGEON, THAT HE WAS PERFORMING A SURGERY PROCEDURE. HE STATED THAT DURING THIS PROCEDURE HE HAD PROBLEMS WITH LOCKING THE LAG SCREW COMPLETELY. HE ALSO NOTICED THAT THE LAG SCREW WENT UP TO THE ATERIA FEMDALIS. FINALLY TO COMPLETE THE SURGERY, HE HAD TO PERFORM A REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREW, T1 10.5X90MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K795920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |