MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-05-19 for RADIAL SMALL, RIGHT 26-3200-R manufactured by Integra Lifesciences Corporation.
[873650]
In a voluntary medwatch received from northern michigan regional hospital, the reporter stated that the total wrist implant fractured and required repair. The patient needed a surgical procedure during which the damaged implant was removed and replaced. Attempts have been made to contact the surgeon by telephone and in writing. No additional information is available to date. Please see also mfr report number 3004608878-2008-00024 for the other wrist implant component report.
Patient Sequence No: 1, Text Type: D, B5
[8086272]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2008-00022 |
| MDR Report Key | 1051684 |
| Report Source | 05,06 |
| Date Received | 2008-05-19 |
| Date of Report | 2008-05-19 |
| Date of Event | 2008-02-20 |
| Date Facility Aware | 2008-02-20 |
| Date Reported to Mfgr | 2008-04-15 |
| Date Mfgr Received | 2008-04-29 |
| Date Added to Maude | 2008-07-22 |
| 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 SCOTT, RN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 4900 CHARLEMAR DRIVE BUILDING A |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIAL SMALL, RIGHT |
| Generic Name | TOTAL WRIST IMPLANT |
| Product Code | KWM |
| Date Received | 2008-05-19 |
| Catalog Number | 26-3200-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1044925 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | CINCINNATI OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2008-05-19 |