MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-24 for CODMAN 53-1417 RN4854 manufactured by Codman & Shurtleff, Inc..
[166112]
Screws fell out of 2 kerrison rongeurs during surgical procedure. Previously repaired by codman 7/99 & 8/99.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018992 |
| MDR Report Key | 279440 |
| Date Received | 2000-05-24 |
| Date of Report | 2000-05-11 |
| Date of Event | 2000-05-11 |
| Date Added to Maude | 2000-05-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN |
| Generic Name | KERRISON RONGUER |
| Product Code | HAD |
| Date Received | 2000-05-24 |
| Model Number | 53-1417 |
| Catalog Number | RN4854 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 270442 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DR. RAYNHAM MA 027676350 US |
| Baseline Brand Name | LUMBAR KERRISON RONGEUR |
| Baseline Generic Name | INSTRUMENT, SURGICAL, MANUAL |
| Baseline Model No | NA |
| Baseline Catalog No | 53-1417 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2000-05-24 |