MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-09 for CODMAN LAMINECTOMY RONGEURS N/A 53-1047 manufactured by Codman.
[19160666]
Patient had a right l5-s1 hernated nucleaus pulposus and was admitted to have a microscopic l5-s1 disectomy on the right. During the operative procedure,a duckbill type of ronger was being used to remove a part of the lamina and the duckbill rongeur superior lip broke off at the screw, and ejected into the dura just to the right of midline. The tip was removed and the tear was easily repaired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10132 |
| MDR Report Key | 10132 |
| Date Received | 1993-08-09 |
| Date of Report | 1993-07-20 |
| Date of Event | 1993-07-07 |
| Date Facility Aware | 1993-07-07 |
| Report Date | 1993-07-20 |
| Date Reported to FDA | 1993-07-26 |
| Date Reported to Mfgr | 1993-07-09 |
| Date Added to Maude | 1993-09-15 |
| 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 | CODMAN LAMINECTOMY RONGEURS |
| Product Code | EMH |
| Date Received | 1993-08-09 |
| Model Number | N/A |
| Catalog Number | 53-1047 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10132 |
| Manufacturer | CODMAN |
| Manufacturer Address | 41 PACELLA PARK DRIVE RANDOLPH MA 02368 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-08-09 |