BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHESIS

    MDR report key: 122020 · Received September 23, 1997

    Report

    Report Number
    MW1012153
    Event Type
    Injury
    Date Received
    September 23, 1997
    Date of Event
    October 11, 1996
    Report Date
    September 11, 1997
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON OCT 11, 1996 RPTR HAD AN ANTERIOR CERVICAL DISCECTOMY AT C-5/6 & C-6/7 LEVELS, AT WHICH TIME 2 TITANIUM PLATES WERE INSTALLED TO AID FUSION. AS RPTR CONTINUED TO HAVE PAIN, AN MRI WAS ORDERED & X-RAYS WERE TAKEN ON MAY 1, 1997, AT WHICH TIME THEY DISCOVERED THAT THE PLATE AT C6/7 WAS BROKEN IN HALF! RPTR DID NOTHING TO CAUSE THIS BREAKAGE & DR AGREED THAT IF SOMETHING HAD HAPPENED TO CAUSE THIS, BOTH OF THEM WOULD HAVE BROKEN. RPTR FEELS IT WAS A DEFECTIVE PLATE. PT SCHEDULED FOR SURGERY TO REMOVE PLATE 9/22/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHESIS Implant TITANIUM PLATE HRS SYNTHES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R| S