BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

    MDR report key: 3142514 · Received June 3, 2013

    Report

    Report Number
    1030489-2013-02053
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C5-7, AND SOMETIME POST-OP, THE PATIENT COMPLAINED OF "PAIN IN HEAD" AND IS "TAKING PAIN MEDICATIONS AND MUSCLE RELAXERS". PER THE REPORT, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH RODS WERE IMPLANTED IN THE NECK. NO FURTHER INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244528 APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CAGE, ALLOGRAFT BONE IMPLANT