BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2033628 · Received March 30, 2011

    Report

    Report Number
    1030489-2011-00357
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 # 75446545, 75446540, 7540020, 8690040. (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. MEDICAL ADVISOR STATES THE PATIENT REPORTEDLY UNDERWENT TITANIUM PEDICLE SCREW FUSION. SUBSEQUENT MRI SOMEHOW REPORTEDLY INDUCED IMPLANTS TO CREATE SECOND DEGREE BURNS OF SKIN OVER IMPLANT. ALTHOUGH IT IS ESTABLISHED THAT FERROMAGNETIC MATERIAL CAN BE CAUSED TO HEAT IN AN MRI FIELD, THIS REPORT DOES NOT APPEAR TO BE EVEN REMOTELY POSSIBLE BECAUSE: TITANIUM IS NOT FERROMAGNETIC AND HAS NOT BEEN SHOWN TO BE AFFECTED BY A MRI FIELD TO THE SAME EXTENT. THE IMPLANTS ARE SEVERAL CENTIMETERS DEEP TO THE SKIN, AND THE AMOUNT OF HEAT NECESSARY TO CAUSE BLISTERING OF THE SKIN WOULD CAUSE LARGE SCALE NECROSIS, CHARRING OF THE SURROUNDING MUSCLE, MYOGLOBINURIA, LARGE SCALE RENAL FAILURE AND BASIC COOKING OF THE PARASPINAL MUSCULATURE. IT IS BELIEVED THAT THE DEVICE DID NOT MALFUNCTION AND IS NOT AT FAULT IN THIS REPORT. THIS REPORT IS FOR NOTIFICATION PURPOSES ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR FUSION SURGICAL PROCEDURE WITH RODS, SCREWS AND VERTEBRAL BODY REPLACEMENT. IT WAS REPORTED THAT SOMETIME POST-OP THE PATIENT UNDERWENT MRI TESTING. DURING THE MRI THE PATIENT EXPERIENCED A BURNING SENSATION ON THE PATIENTS BACK. THE PATIENT WAS EXAMINED BY A DOCTOR WHO DIAGNOSED THE PATIENT WITH SECOND DEGREE BURNS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP MEDTRONIC SOFAMOR DANEK NA NA

    Patients

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