COLIBRI II Adverse Event — Malfunction (MDR 8030965-2020-03104)
COLIBRI II Adverse Event — Malfunction (MDR 8030965-2020-03104) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COLIBRI II; Generic name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A; Manufacturer: DEPUY SYNTHES PRODUCTS LLC.
| Device | COLIBRI II |
|---|---|
| Generic name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS A |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Report number | 8030965-2020-03104 |
| 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 DETERMINED TO BE DUE TO COMPONENT FAILURE |
| Source | openFDA MAUDE (device adverse events) |
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