MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-06-09 for CARPAL POLY MEDIUM-STD 262300 manufactured by Integra Lifesciences Corporation (integra-ohio).
[1404921]
The distributor reported that a surgeon had noticed several cases where the carpal component of the uni 2 prosthesis had moved forward. The stem moves forward and the screws remain at the original position. Subsequently, the screws separate from the component and as a result, this misaligns the poly and leads to a luxation. In one reported case, the pt had no revision done. No lot or product identification reference numbers were provided by the reporter. Integra has requested additional info.
Patient Sequence No: 1, Text Type: D, B5
[8622839]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3004608878-2010-00048 |
MDR Report Key | 1728846 |
Report Source | 01,08 |
Date Received | 2010-06-09 |
Date of Report | 2010-06-09 |
Date of Event | 2010-04-28 |
Date Mfgr Received | 2010-05-04 |
Date Added to Maude | 2011-04-27 |
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 | SUSAN SCOTT |
Manufacturer Street | 311 ENTERPRISE DR |
Manufacturer City | PLAINSBORO NJ 08536 |
Manufacturer Country | US |
Manufacturer Postal | 08536 |
Manufacturer Phone | 6099363604 |
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 | 2010-06-09 |
Catalog Number | 262300 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO) |
Manufacturer Address | PLAYA DEL REY CA 90293 US 90293 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2010-06-09 |