MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2008-05-23 for E-CENTRIX ULNAR HEAD 596H-1815 manufactured by Wright Medical Technology, Inc..
[18513444]
Allegedly pt reviewed in january due to pain and swelling. Clinically presenting as "overstuffing", so head revised to 16mm x 1. 5 head.
Patient Sequence No: 1, Text Type: D, B5
[18722049]
Investigation is not complete. Trends will be evaluated. Add'l info has been requested. This report will be amended when the investigation is complete. This even occurred in another country.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2008-00120 |
| MDR Report Key | 1050336 |
| Report Source | 01 |
| Date Received | 2008-05-23 |
| Date of Report | 2008-05-06 |
| Date of Event | 2007-01-30 |
| Date Facility Aware | 2007-01-30 |
| Date Mfgr Received | 2008-05-06 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2008-05-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN ANDERSON |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674140 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE RD. |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-CENTRIX ULNAR HEAD |
| Product Code | KXE |
| Date Received | 2008-05-23 |
| Catalog Number | 596H-1815 |
| Lot Number | 056299932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1020329 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | ARLINGTON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-05-23 |