MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-23 for SCREW EXTRACTOR 2.5MM * manufactured by Depuy Spine, Inc..
[2318121]
Elderly female undergoing removal of painful extensive lumbar segmental instrumentation l3-5: two 2. 5 mm set screw extractors from the screw removal set broke off in the patient hardware during lumbar-hardware removal. All pieces were recovered from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2355534 |
| MDR Report Key | 2355534 |
| Date Received | 2011-11-23 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-10-12 |
| Report Date | 2011-11-22 |
| Date Reported to FDA | 2011-11-23 |
| Date Added to Maude | 2011-12-01 |
| 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 | SCREW EXTRACTOR 2.5MM |
| Generic Name | SET-SCREW EXTRACTORS/SCREW REMOVAL SET |
| Product Code | HWP |
| Date Received | 2011-11-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-23 |