FDA Adverse Event
Malfunction
Summary report: N
EXETER 2.5 I M PLUG 14MM
MDR report key: 1962921
·
Received December 22, 2010
Report
- Report Number
- 9610726-2010-00491
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 11, 2010
- Report Date
- December 13, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LZN
- PMA / PMN Number
- K980843
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON OPENING THE IMPLANT, THE TIP OF THE BONE PLUG APPEARED TO BE BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER 2.5 I M PLUG 14MM | IMPLANT | LZN | STRYKER ORTHOPAEDICS LIMERICK | NA | L91SM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |