STABILIZATION SCREW 3MM DIA X 20MM LENGTH STERILE Adverse Event — Malfunction (MDR 9615741-2008-00002)
STABILIZATION SCREW 3MM DIA X 20MM LENGTH STERILE Adverse Event — Malfunction (MDR 9615741-2008-00002) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: STABILIZATION SCREW 3MM DIA X 20MM LENGTH STERILE; Generic name: STABILIZATION SCREW; Manufacturer: NEWDEAL S.A..
| Device | STABILIZATION SCREW 3MM DIA X 20MM LENGTH STERILE |
|---|---|
| Generic name | STABILIZATION SCREW |
| Manufacturer | NEWDEAL S.A. |
| Report number | 9615741-2008-00002 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Distributor |
| Narrative | IT WAS REPORTED BY THE DISTRIBUTOR ON BEHALF OF THE USER FACILITY, THAT THE SURGEON WANTED TO USE A QWIX SCREW, DIAMETER 3MM LENGTH AND 20MM WITHOUT DRILLING THE CORTEX BONE. DURING THE INSERTION OF THE SCREW INTO THE BONE, THE TIP OF THE SCREW BROKE. |
| Source | openFDA MAUDE (device adverse events) |
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