BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 12

    MDR report key: 1233639 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-05555
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 28, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE REPORTED PRODUCT/LOT NUMBER WAS PART OF A BATCH OF PRODUCTS WHICH WERE SUSCEPTIBLE TO FRACTURE. THE ETCH LOCATION WAS CHANGED BY A DESIGN REVISION IN LATE 2002. A RECALL WAS CONDUCTED, IN EUROPE, TO REMOVE ALL AFFECTED PRODUCTS FROM THE MARKET. NOTE - AFFECTED PRODUCT WAS NOT DISTRIBUTED IN THE U.S., AS U.S. DISTRIBUTION DID NOT BEGIN UNTIL 2005. SHOULD ADD'L INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    CORAIL AMT NECK FRACTURE. FALL WHEN WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT COLLAR SIZE 12 87KWA KWA DEPUY FRANCE S.A. NA 1320082

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention