SIMPLEX P - US FULL DOSE 10-PK Adverse Event — Malfunction (MDR 9610726-2008-00005)
SIMPLEX P - US FULL DOSE 10-PK Adverse Event — Malfunction (MDR 9610726-2008-00005) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SIMPLEX P - US FULL DOSE 10-PK; Generic name: IMPLANT; Manufacturer: STRYKER ORTHOPAEDICS LIMERICK.
| Device | SIMPLEX P - US FULL DOSE 10-PK |
|---|---|
| Generic name | IMPLANT |
| Manufacturer | STRYKER ORTHOPAEDICS LIMERICK |
| Report number | 9610726-2008-00005 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | Company representation |
| Narrative | IT WAS REPORTED THAT THE SIMPLEX CEMENT SET UP TOO QUICKLY - 8 MINUTES - AS OPPOSED TO THE EXPECTED 12 TO 14 MINUTES. SIMPLEX WAS STORED IN ITS NORMAL LOCATION. |
| Source | openFDA MAUDE (device adverse events) |
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