FDA Adverse Event
Injury
Summary report: N
LAG SCREW, TI 10.5X120MM
MDR report key: 1241585
·
Received November 21, 2008
Report
- Report Number
- 9610622-2008-00245
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 31, 2008
- Report Date
- October 31, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- PMA / PMN Number
- K034002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 THAT, "LAG SCREW WAS RUBBING AGAINST IT BAND AND CAUSING PAIN, SO PATIENT WANTED IT REMOVED. ALL OTHER IMPLANTS WERE STABLE AND LEFT IN THE PATIENT. PATIENT SPECIFIED TO DOCTOR THAT HE WANTED TO KEEP THE ITEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREW, TI 10.5X120MM | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | K762909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |