FDA Adverse Event
Malfunction
Summary report: N
EXETER 2.5 I M PLUG 14MM
MDR report key: 2140726
·
Received May 31, 2011
Report
- Report Number
- 9610726-2011-00175
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 12, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JDI
- PMA / PMN Number
- K980843
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR. #9610726-2011-00176 AND 9610726-2011-00177.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA THE SALES REP THAT FOUR SIZE 14 EXETER PLUGS FRACTURED WITHIN ONE WEEK. NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER 2.5 I M PLUG 14MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS LIMERICK | NA | L5424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |