MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for MEDTRONIC 2900164 manufactured by Medtronic Sofamor Danek, Inc.
[118259327]
Collet holding the screw came loose during use. The screw dropped into patient, seen on flouro, removed screw
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7816314 |
| MDR Report Key | 7816314 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-08-08 |
| Report Date | 2018-08-22 |
| Date Reported to FDA | 2018-08-22 |
| Date Reported to Mfgr | 2018-08-27 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | HTS |
| Date Received | 2018-08-27 |
| Model Number | 2900164 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK, INC |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-27 |