BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 3766514 · Received April 23, 2014

    Report

    Report Number
    1030489-2014-02270
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 7575540, # 7576535, # 8672055, # 2991022, # 7570955, # 2990822, AND # 8672065. 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 THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SCREWS WERE FOUND TO HAVE FAILED; THE SCREWS HAD ENLARGED THEIR HOLES (HALO EFFECT AROUND SCREWS). IT WAS REPORTED THAT THE PATIENT HAS NOT FUSED. THE PATIENT WAS CONCERNED THAT THE METALS CAUSED AN ALLERGIC REACTION CAUSING FUSION TO FAIL. THE PATIENT WILL NEED TO UNDERGO AN ADDITIONAL SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245516 N/A APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS, RODS, VB REPLACEMENT