MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-20 for PROSTHETIC RADIAL HEAD manufactured by Wright Medical Technologies.
[200500]
"a radial head replacement arthroplasty using wright modular radial head prosthesis, 9. 5 mmstem, 28 mm/0 head component". This component was used after the pt had suffered a fracture dislocation of their left elbow. The surgical procedure was to excise the radial head and place a prosthetic radial head in position to recontruct that element and provide better stabilization of the elbow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 310681 |
| MDR Report Key | 310681 |
| Date Received | 2000-12-20 |
| Date of Report | 2000-12-12 |
| Date of Event | 2000-11-14 |
| Date Facility Aware | 2000-12-08 |
| Report Date | 2000-12-12 |
| Date Reported to Mfgr | 2000-12-12 |
| Date Added to Maude | 2001-01-05 |
| 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 | NI |
| Generic Name | PROSTHETIC RADIAL HEAD |
| Product Code | KIG |
| Date Received | 2000-12-20 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 099A108123 |
| ID Number | REF: 496-H028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 20 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 300546 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGIES |
| Manufacturer Address | P.O. BOX 100 ARLINGTON TN 38002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-12-20 |