MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for ORTHOSIS, SPINAL PEDICLE FIXATION manufactured by Reliance Medical Systems, Llc.
[173465317]
Tip of straight pedicle probe broke off in patient bone, approximately 3mm in diameter and approximately 20mm in length was left in the patient bone. Tip left in patient per surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9543049 |
| MDR Report Key | 9543049 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-24 |
| Date of Event | 2019-12-18 |
| Report Date | 2019-12-24 |
| Date Reported to FDA | 2019-12-24 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | ORTHOSIS, SPINAL PEDICLE FIXATION |
| Product Code | MNI |
| Date Received | 2020-01-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 545 WEST 500 SOUTH STE. 100 BOUNTIFUL UT 84010 US 84010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |