MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-07 for LUCAE MALLET, 8", BRONZE HEAD * 250-408 manufactured by *.
[769831]
It was reported that the mallet head broke off from the handle, during spinal surgery and landed on the patient's spine. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2007-00052 |
| MDR Report Key | 961692 |
| Date Received | 2007-12-07 |
| Date of Report | 2007-12-07 |
| Date Facility Aware | 2007-11-19 |
| Report Date | 2007-12-07 |
| Date Added to Maude | 2007-12-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUCAE MALLET, 8", BRONZE HEAD |
| Generic Name | ORTHOPEDIC SURGICAL INSTRUMENT |
| Product Code | HXL |
| Date Received | 2007-12-07 |
| Model Number | * |
| Catalog Number | 250-408 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 931718 |
| Manufacturer | * |
| Manufacturer Address | * * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-07 |