MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-21 for BONE CURRETTE-FORWARD ANGLED CUP 3.6 CM * manufactured by Medtronic.
[2393535]
During procedure, the curette broke in half, both pieces were recovered from the operative field. The procedure was completed without further incident. There was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2471358 |
| MDR Report Key | 2471358 |
| Date Received | 2012-02-21 |
| Date of Report | 2012-02-21 |
| Date of Event | 2011-12-05 |
| Report Date | 2012-02-21 |
| Date Reported to FDA | 2012-02-21 |
| Date Added to Maude | 2012-02-28 |
| 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 | BONE CURRETTE-FORWARD ANGLED CUP 3.6 CM |
| Generic Name | BONE CURETTE |
| Product Code | HTF |
| Date Received | 2012-02-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 4340 SWINNEA RD. MPHS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-21 |