BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES ANTERIOR CERVICAL PLATE

    MDR report key: 92949 · Received May 21, 1997

    Report

    Report Number
    92949
    Event Type
    Malfunction
    Date Received
    May 21, 1997
    Date of Event
    May 6, 1997
    Report Date
    May 9, 1997
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 74 YR OLD FEMALE PT UNDERWENT A PROCEDURE ON DECEMBER 22, 1996 TO HAVE A SYNTHES ANTERIOR CERVICAL PLATE AFFIXED TO HER SPINE. SOMETIME OVER THE NEXT 4 MONTHS THE PLATE BROKE AND SEPARATED. THE PT UNDERWENT ANOTHER PROCEDURE ON 5/6/97 TO REMOVE AND REPLACE THE ANTERIOR CERVICAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES ANTERIOR CERVICAL PLATE CERVICAL LOCKING SET JDN SYNTHES (USA) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR