MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-22 for MORELAND GEAR * 6020-10-DEPUY manufactured by Depuy Orthopaedics, Inc..
[18911381]
The surgeon was attempting to remove sclerotic bone with one of the reverse curettes from the moreland gear. The tip broke off and remained in the patient. The physician attempted to retrieve the tip, but was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 805898 |
| MDR Report Key | 805898 |
| Date Received | 2006-12-22 |
| Date of Report | 2006-12-22 |
| Date of Event | 2006-12-14 |
| Report Date | 2006-12-22 |
| Date Reported to FDA | 2006-12-22 |
| Date Added to Maude | 2007-01-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORELAND GEAR |
| Generic Name | ORTHOPEDIC REVERSE CURETTE |
| Product Code | FZS |
| Date Received | 2006-12-22 |
| Model Number | * |
| Catalog Number | 6020-10-DEPUY |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 793391 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | A JOHNSON AND JOHNSON COMPANY 700 ORTHOPEDIC DRIVE WARSAW IN 46581 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-22 |