MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for 6.5 CANCELLOUS BONE SCREWS (80 MM X 2) LA 382S manufactured by Aesculap.
[11897]
Patient had ankle fusion with screws implanted on 4/8/91. On october 18, 1991, removal of 4 screws and orif with plate and eight screws implanted for pseudoarthrosisin february onset of pain in right ankle with weight bearing. On 3/28/94, patient returned to surgery for removal of tubular plate and eight screws. Five proximal screws were removed from the plate. Three transverse screws (6. 5 cancellous bone screws) were broken and removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17682 |
| MDR Report Key | 17682 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-03-28 |
| Date of Event | 1994-03-23 |
| Date Facility Aware | 1994-03-23 |
| Report Date | 1994-03-28 |
| Date Reported to Mfgr | 1994-03-28 |
| 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 | 6.5 CANCELLOUS BONE SCREWS (80 MM X 2) |
| Generic Name | BONE SCREWS |
| Product Code | HWD |
| Date Received | 1994-07-29 |
| Catalog Number | LA 382S |
| Device Availability | N |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17599 |
| Manufacturer | AESCULAP |
| Manufacturer Address | 1000 GATEWAY BLVD. SOUTH SAN FRANCISCO CA 94080 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1994-07-29 |