BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPAR PLATE AND SCREW

    MDR report key: 19909 · Received February 21, 1995

    Report

    Report Number
    MW1005193
    Event Type
    Injury
    Date Received
    February 21, 1995
    Report Date
    February 6, 1995
    Manufacturer
    AESCULAP INSTRUMENTS CORP.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 11/26/90, RPTR HAD ANTERIOR CERVICAL FUSION OF C5-6 C6-7 WITH PLATES AND 6 SCREWS. IN 12/91 X-RAYS SHOWED SCREWS HAD LOOSENED AND PLATE WAS LOOSE, DR LEFT THEM IN UNTIL 10/92. PRTR HAD SEVERE PAIN IN NECK, SWALLOWING PROBLEMS. HAD A BARIUM SWALLOW DONE TO SEE IF SCREWS HAD ERODED ESOPHAGUS AWAY AND COME THROUGH BEFORE SURGERY TO REMOVE HARDWARE. RPTR'S THROAT STILL HURTS, POSS ESOPHAGUS EROSION, DAMAGE TO VERTEBRAE AND ADD'L SURGERY AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPAR PLATE AND SCREW Implant SPINAL SCREW KWQ AESCULAP INSTRUMENTS CORP. 50 MM, 22 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R