BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES USA

    MDR report key: 17703 · Received July 29, 1994

    Report

    Report Number
    17703
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    August 1, 1993
    Report Date
    April 7, 1994
    Manufacturer
    SYNTHES USA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    4/93 PATIENT HAD C5-C6 ANTERIOR FUSION WITH INSTRUMENTATION WITH AO TITANIUM PLATE FIXATION. A FRACTURE OF THE INFERIOR PORTION OF THE PLATE WAS IDENTIFIED APPROX. 4 1/2 MONTHS AFTER SURGERY.4/94 PATIENT HAD SURGERY - REMOVAL OF INSTRUMENTATION AND C5-C7 FUSION WITH ILIAC GRAFT AND TONGS PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA Implant A-0 CERVICAL TITANIUM LATE SYNTHES USA 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 48 * Hospitalization