BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X24MM

    MDR report key: 2854049 · Received December 3, 2012

    Report

    Report Number
    1818910-2012-28484
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWS
    PMA / PMN Number
    K081620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REJECTING COMPLAINT AS A DUPLICATE OF MANUFACTURING REPORT NUMBER 1818910-2012-28387.

    Additional Manufacturer Narrative · 1

    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 PRESENTED WITH PAIN AND DECREASED RANGE OF MOTION. X-RAY REVEALED LOOSE METAGLENE. REVISION SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND SCREW LOCK D4.5X24MM DEPUY SHOULDER IMPLANT KWS DEPUY FRANCE 5080657

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention