ACTIS RETAINING STEM INSERTER Adverse Event — Malfunction (MDR 1818910-2020-11388)
ACTIS RETAINING STEM INSERTER Adverse Event — Malfunction (MDR 1818910-2020-11388) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACTIS RETAINING STEM INSERTER; Generic name: INSERTION DEVICES; Manufacturer: DEPUY IRELAND - 9616671.
| Device | ACTIS RETAINING STEM INSERTER |
|---|---|
| Generic name | INSERTION DEVICES |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Report number | 1818910-2020-11388 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY AS NOT SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES C |
| Source | openFDA MAUDE (device adverse events) |
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