CARPAL POLY MEDIUM - STD
Received Apr 5, 2013
Report 3004608878-2013-00060 · MDR key 3052952
Device
Generic name
Uni2 Total Wrist Implant System
Manufacturer
Integra Lifesciences CorporationCatalog number
262300
Product problems
- Material Integrity Problem
- Naturally Worn
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.