FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P - US TOBRA FD 10-PK
MDR report key: 2191403
·
Received July 28, 2011
Report
- Report Number
- 9610726-2011-00268
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 8, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- K014199
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SIMPLEX WITH TOBRA BONE CEMENT EXPIRED ON (B)(4) 2011 AND WAS IMPLANTED ON (B)(6) 2011."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P - US TOBRA FD 10-PK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | MJQ065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |