FDA Adverse Event
Malfunction
Summary report: N
EXETER 2.5 I M PLUG 16MM
MDR report key: 2883473
·
Received November 14, 2012
Report
- Report Number
- 9610726-2012-00352
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 25, 2012
- Report Date
- October 26, 2012
- 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SALES REP REPORTED ON BEHALF OF THE CUSTOMER THAT TWO PLUGS BROKE DURING SURGERY INSIDE THE PATIENT AND THAT ONE COULD BE RETRIEVED, THE OTHER ONE WAS LEFT IN SITU. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXETER 2.5 I M PLUG 16MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS LIMERICK | NA | L6008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |