MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-15 for MORELAND 602012 * manufactured by Depuy Orthopaedics, Inc..
[1781574]
While removing well-fixed cement from within the canal and once the cement restrictor was also removed, it was noted that the moreland instrument (one of the small hooks) was missing its tip after this extraction device was used. Multiple attempts were made to retrieve the missing tip. Post-operative radiograph revealed film that was "good. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1943998 |
| MDR Report Key | 1943998 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-12-14 |
| Date of Event | 2010-12-03 |
| Report Date | 2010-12-14 |
| Date Reported to FDA | 2010-12-15 |
| Date Added to Maude | 2011-01-03 |
| 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 | 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 |
| Generic Name | CEMENT EXTRACTOR |
| Product Code | JDY |
| Date Received | 2010-12-15 |
| Model Number | 602012 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 46581 US 46581 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-15 |