DVR ANATOMIC EXT LEFT Adverse Event — Injury (MDR 0001825034-2020-01796)
DVR ANATOMIC EXT LEFT Adverse Event — Injury (MDR 0001825034-2020-01796) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DVR ANATOMIC EXT LEFT; Generic name: PLATE, FIXATION; Manufacturer: ZIMMER BIOMET, INC..
| Device | DVR ANATOMIC EXT LEFT |
|---|---|
| Generic name | PLATE, FIXATION |
| Manufacturer | ZIMMER BIOMET, INC. |
| Report number | 0001825034-2020-01796 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE PLATE IS FRACTURED AT THE SCREW HOLES. X-RAYS PROVIDED WERE SENT TO THE HCP FOR REVIEW. THEIR REVIEW NOTED THE OVERALL FIT OF THE IMPLANTS APPEARS NORMAL. AS A RESULT OF THE PLATE FRACTURE, THERE IS ABNORMAL ALIGNMENT WITH APEX VOLAR ANGULATION OF THE BONE AND PLATE. |
| Source | openFDA MAUDE (device adverse events) |
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