FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT 5.0 SCREWS
MDR report key: 1032845
·
Received April 22, 2008
Report
- Report Number
- 9610622-2008-00046
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- April 2, 2008
- Report Date
- April 3, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE DISCARDED BY HOSPITAL. NO EVALUATION WILL BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "3 SCREWS REMOVED FROM AN ANKLE ARTHRODESIS NAIL DUE TO SKIN IRRITATION".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT 5.0 SCREWS | IMPLANT | HWC | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |