MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-20 for OSCAR 3 LAO6734 ISS:01 manufactured by Orthofix Inc..
[65373375]
Patient Sequence No: 1, Text Type: N, H10
[65373376]
The tip of the oscar became engaged in the distal most portion of the cement and fractured. Attempt to retrieve the tip of the oscar and cement plug was unsuccessful and was therefore abandoned
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6266006 |
| MDR Report Key | 6266006 |
| Date Received | 2017-01-20 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-10-17 |
| Report Date | 2017-01-10 |
| Date Reported to FDA | 2017-01-10 |
| Date Reported to Mfgr | 2017-01-10 |
| Date Added to Maude | 2017-01-20 |
| 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 | OSCAR 3 |
| Generic Name | SYSTEM, CEMENT REMOVAL EXTRACTION |
| Product Code | LZV |
| Date Received | 2017-01-20 |
| Catalog Number | LAO6734 ISS:01 |
| Lot Number | WO/22724/A |
| ID Number | 1 OMM PEIRCER PROBE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX INC. |
| Manufacturer Address | CHRISTOPHER HACK 3451 PLANO PARKWAY LEWISVILLE TX 75056 US 75056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-20 |