BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARPAL POLY MEDIUM-STD

    MDR report key: 1728846 · Received June 9, 2010

    Report

    Report Number
    3004608878-2010-00048
    Event Type
    Other
    Date Received
    June 9, 2010
    Date of Event
    April 28, 2010
    Report Date
    June 9, 2010
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO)
    Product Code
    KWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPAL POLY MEDIUM-STD UNI2 TOTAL WRIST IMPLANT SYSTEM KWN INTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other