BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 12

    MDR report key: 1210528 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-05046
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 16, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 2002. A RECALL WAS CONDUCTED, IN ANOTHER COUNTRY, 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 ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    NECK FRACTURE OF CORAIL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORAIL AMT COLLAR SIZE 12 87KWA KWA DEPUY FRANCE S.A. NA 1257851

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention