FDA Adverse Event
Malfunction
Summary report: N
SIMPLEX P FULL DOSE 1 PACK
MDR report key: 2231587
·
Received July 22, 2011
Report
- Report Number
- 9610726-2011-00263
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Report Date
- July 5, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LOD
- PMA / PMN Number
- N17004
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- 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. PRODUCT WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGICAL TECHS OPENED AND MIXED CEMENT AND NOTICED BLACK CHIPS IN THE POWDER. THEY DETERMINED IT WAS BEST TO NOT USE THE BATCH OR CASE OF CEMENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMPLEX P FULL DOSE 1 PACK | IMPLANT | LOD | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |