MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-05 for CARPAL POLY MEDIUM - STD 262300 manufactured by Integra Lifesciences Corporation.
[3364674]
The surgeon gave integra reps an explanted universal 2 total wrist carpal poly (standard medium size) during a meeting as an example of poly wear. The part showed delamination and wear of the articular surface. There was patient contact and revision was required. Add'l info was requested but as per surgeon, he did not have any of the requested info and there was no way for him to find it as he now knows that this particular implant was sent to him by another surgeon.
Patient Sequence No: 1, Text Type: D, B5
[10625863]
To date, the device involved in the reported incident has been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2013-00060 |
| MDR Report Key | 3052952 |
| Report Source | 05,07 |
| Date Received | 2013-04-05 |
| Date of Report | 2013-04-05 |
| Date Mfgr Received | 2013-03-20 |
| Date Added to Maude | 2013-04-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA SALVADOR |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 4900 CHARLEMAR DR. 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 | CARPAL POLY MEDIUM - STD |
| Generic Name | UNI2 TOTAL WRIST IMPLANT SYSTEM |
| Product Code | KWN |
| Date Received | 2013-04-05 |
| Catalog Number | 262300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 4900 CHARLEMAR DR., BUILDING A CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-05 |