BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES USA

    MDR report key: 193534 · Received October 23, 1998

    Report

    Report Number
    193534
    Event Type
    Injury
    Date Received
    October 23, 1998
    Date of Event
    September 23, 1998
    Report Date
    September 24, 1998
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    5/95 - PT HAD ANTERIOR CERVICAL DISKECTOMY AND FUSION OF CERVICAL VERTABRAE 4-5 AND CERVICAL VERTEBRAE 5-6. 1/96 IN AUTO ACCIDENT DEVELOPED NECK AND ARM PAIN. X-RAY SHOWED SOLID FUSION AND PHYSICAL THERAPY STARTED. PT RETURNS NOW WITH NECK AND SHOULDER PAIN. X-RAYS SHOW THAT ANTERIOR PLATE IS BROKEN AT LOWER LEVEL. PLATE REMOVED AND ANTERIOR CERVICAL DISKECTOMY AND FUSION OF CERVICAL VERTABRAE 3-4 DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USA Implant CERVICAL PLATE KWQ SYNTHES (USA) A400767 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention