BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL SPINE LOCKING PLATE/26MM

    MDR report key: 186444 · Received September 8, 1998

    Report

    Report Number
    2520274-1998-00061
    Event Type
    Injury
    Date Received
    September 8, 1998
    Date of Event
    August 3, 1998
    Report Date
    August 7, 1998
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUBJECT DEVICE WAS IMPLANTED ON 04/09/1998. POST-OPERATIVELY, THE DEVICE WAS FOUND TO BE BROKEN AND ON 08/03/1998 WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVICAL SPINE LOCKING PLATE/26MM Implant LOCKING PLATE KWQ SYNTHES (USA) NA A4GM629

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention (04/09/1998 TO 08/03/1998)| 1.LOCKING SCREWS.2.EXPANSIONHEAD SCREWS