BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1882851 · Received October 14, 2010

    Report

    Report Number
    1030489-2010-01328
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR FIXATION L3-S1 WITH PLIF AT L3 / L4. WHEN FIXING THE ROD, IT WAS OBSERVED THAT THE ROD HAD A LITTLE SPACE. THE NUT BROKE TOO EASILY AND THE ROD WAS STILL MOVING A LITTLE BIT. THE SURGEON THEN TOOK THE SCREWDRIVER AND DROVE THE SCREW 2 TURNS INTO THE BONE, NOW THE SCREW HAD DIRECT CONTACT WITH THE BONE. SURGEON FIXED AGAIN THE ROD, IT HOLD, BROKE THE NUT, NO MORE SPACE OR MOVING WAS SEEN AND FELT, END OF SURGERY. THERE IS NO REPORT OF PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM PEEK ROD SCREW KWQ MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR