MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-18 for UNK manufactured by Unk.
[375975]
Pt in operating room having excision of intervertebral lumbar disc with fusion/refusion. Surgeon noticed downbiter pituitary rongeur was missing a screw after using it. Scrub technician did not notice if screw was missing before use. X-ray was done and no screw was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 567440 |
| MDR Report Key | 567440 |
| Date Received | 2005-01-18 |
| Date of Report | 2005-01-17 |
| Date of Event | 2004-12-21 |
| Date Facility Aware | 2005-01-17 |
| Report Date | 2005-01-17 |
| Date Reported to FDA | 2005-01-17 |
| Date Added to Maude | 2005-01-26 |
| 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 | UNK |
| Generic Name | DOWNBITER PITUITARY RONGEUR |
| Product Code | EMH |
| Date Received | 2005-01-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 557252 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-18 |