FDA Adverse Event
Malfunction
Summary report: N
EXETER 2.5 I M PLUG 14MM
MDR report key: 1713503
·
Received June 1, 2010
Report
- Report Number
- 9610726-2010-00175
- Event Type
- Malfunction
- Date Received
- June 1, 2010
- Date of Event
- May 17, 2010
- Report Date
- May 17, 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
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN AN SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, "CEMENT RESTRICTOR BROKE WHILE BEING INSERTED INTO CANAL - A 2ND RESTRICTOR OF THE SAME SIZE WAS THEN USED WITHOUT ANY ISSUES."
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 | L4576 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |