FDA Adverse Event
Malfunction
Summary report: N
NAIL ADAPTER
MDR report key: 2132470
·
Received June 14, 2011
Report
- Report Number
- 9610622-2011-00259
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, THE NAIL CONNECTION PIECE CRACKED. COULD HAVE HAPPENED IN A PREVIOUS SURGERY, BUT WAS NOT CAUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAIL ADAPTER | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |