MOTOR ASSEMBLY, XMAX Adverse Event — Malfunction (MDR 1045834-2020-00716)
MOTOR ASSEMBLY, XMAX Adverse Event — Malfunction (MDR 1045834-2020-00716) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MOTOR ASSEMBLY, XMAX; Generic name: MOTOR, DRILL, ELECTRIC - HANDPIECE; Manufacturer: DEPUY SYNTHES PRODUCTS LLC.
| Device | MOTOR ASSEMBLY, XMAX |
|---|---|
| Generic name | MOTOR, DRILL, ELECTRIC - HANDPIECE |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Report number | 1045834-2020-00716 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS TRACED TO COMPONENT FAILURE DUE TO NORMAL |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →