BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X30MM

    MDR report key: 6193088 · Received December 21, 2016

    Report

    Report Number
    1818910-2016-33799
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    DEPUY FRANCE 3003895575
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT/LOT COMBINATION SINCE RELEASE FOR DISTRIBUTION. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS METAGLENE LOOSENING, NON-CEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842990 DXTEND SCREW LOCK D4.5X30MM SHOULDER OTHER IMPLANT HSD DEPUY FRANCE 3003895575 5265111

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention