MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for ORTHOFIX manufactured by Orthofix Inc..
[105686642]
Patient Sequence No: 1, Text Type: N, H10
[105686643]
Screwdriver tip broke while implanting screw.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7435690 |
| MDR Report Key | 7435690 |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-30 |
| Report Date | 2018-04-06 |
| Date Reported to FDA | 2018-04-06 |
| Date Reported to Mfgr | 2018-04-06 |
| Date Added to Maude | 2018-04-17 |
| 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 |
| 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 | ORTHOFIX |
| Generic Name | DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT |
| Product Code | JDO |
| Date Received | 2018-04-17 |
| ID Number | TRY-IN 11 00-N |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX INC. |
| Manufacturer Address | 3451 PLANO PARKWAY LEWISVILLE TX 75056 US 75056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-17 |