MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-20 for MEAD MALLET 7-1/2 W/NYLON CAPS 19-796 250-415 manufactured by Integra.
[2254996]
During acdf (anterior cerical diskectomy and fusion), the surgeon was checking the size of spacer needed with trial and handle. The nylon face of the mallet broke over the surgical field. All pieces of the nylon face were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2274824 |
| MDR Report Key | 2274824 |
| Date Received | 2011-09-20 |
| Date of Report | 2011-09-20 |
| Date of Event | 2011-09-16 |
| Report Date | 2011-09-20 |
| Date Reported to FDA | 2011-09-20 |
| Date Added to Maude | 2011-10-04 |
| 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 | MEAD MALLET 7-1/2 W/NYLON CAPS |
| Generic Name | NEUROSURGERY SURGICAL MALLET |
| Product Code | GFJ |
| Date Received | 2011-09-20 |
| Model Number | 19-796 |
| Catalog Number | 250-415 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA |
| Manufacturer Address | 589 DAVIES DR YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-20 |