BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL SPINE LOCKING PLATE

    MDR report key: 176109 · Received July 7, 1998

    Report

    Report Number
    1719045-1998-00020
    Event Type
    Injury
    Date Received
    July 7, 1998
    Date of Event
    June 4, 1998
    Report Date
    July 6, 1998
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS IMPLANTED IN THE PT ON 4/21/1997. LATER IS WAS FOUND THAT THERE WAS A POSSIBLE NON-UNION AND THAT THE DEVICE HAD BROKEN. ON 6/4/1998, A SURGERY WAS PERFORMED TO REMOVE THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERVICAL SPINE LOCKING PLATE Implant LOCKING PLATE JDN SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention LOCKING SCREWS, EXPANSIONHEAD SCRW (UNK TO 6/4/98)