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 |