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 |