MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for 7 HOLE SEMI-TUBULAR PLATE SCREWS: LA 2 = LENGTH OF SCREW manufactured by Aesculap.
[6398]
On 12/20/93, patient underwent orif right humerus with iliac crest bone graft for non-union of fracture sustained three years prior in california and treated non-operatively at that time. Postoperatively, she developed a mild radial nerve palsy which was treated with physical therapy. Follow up radiographs revealed backing out of four of the screws of the fixation. On 1/26/94, underwent surgery for removal of screws and orif. The four distal screws were loose with three of the four screws out of the plate and bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17656 |
| MDR Report Key | 17656 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-02-02 |
| Date of Event | 1994-01-26 |
| Date Facility Aware | 1994-01-26 |
| Report Date | 1994-02-02 |
| Date Added to Maude | 1994-11-15 |
| 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 | 7 HOLE SEMI-TUBULAR PLATE |
| Generic Name | 4.5 MALLEOLAR SCREWS X 7 |
| Product Code | HWD |
| Date Received | 1994-07-29 |
| Catalog Number | SCREWS: LA 2 = LENGTH OF SCREW |
| Device Availability | N |
| Device Age | 1 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17573 |
| Manufacturer | AESCULAP |
| Manufacturer Address | 1000 GATEWAY BLVD. SOUTH SAN FRANCISCO CA 94080 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-07-29 |