MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-23 for MEDTRONIC SOFAMOR DANEK * 9560565 manufactured by Medtronic Sofamor Danek.
[340102]
While removing disc (l 4-5) from disc space pituitary biter tip broke off in disc space, several attempts, to retrieve the tip, by surgeon utilizing x-ray and several instruments were unsuccessful. Surgeon states more of a risk to continue attempt or removal than to leave in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 546785 |
| MDR Report Key | 546785 |
| Date Received | 2004-09-23 |
| Date of Report | 2004-09-21 |
| Date of Event | 2004-09-20 |
| Date Facility Aware | 2004-09-20 |
| Report Date | 2004-09-21 |
| Date Reported to FDA | 2004-09-22 |
| Date Reported to Mfgr | 2004-09-21 |
| Date Added to Maude | 2004-10-04 |
| 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 | 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 | MEDTRONIC SOFAMOR DANEK |
| Generic Name | SPINAL PITUITARY (1 MM) BITER |
| Product Code | GZX |
| Date Received | 2004-09-23 |
| Returned To Mfg | 2004-09-20 |
| Model Number | * |
| Catalog Number | 9560565 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 536194 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-09-23 |