BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2855020 · Received December 3, 2012

    Report

    Report Number
    1030489-2012-02524
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    NKB
    PMA / PMN Number
    K051674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE INSTRUMENT DID NOT REVEAL ANY MATERIAL OR FUNCTIONAL DAMAGE IN TERMS OF FRACTURE, CRACKING, OR BREAKAGE. MANUAL EVALUATION FOUND THE -05 INSERTER SUBASSEMBLY LOOSE AT THE MAIN BODY ATTACHMENT POINT. ROD INSERTER ATTACHMENT ARMS AND LEVERS OPEN AND CLOSE AND FUNCTION NORMALLY. ROD INSERTER ROD ATTACHMENT LEVER OPENS NORMALLY AND SECURELY RETAINED SAMPLE ROD WHEN CLOSED. SAMPLE ROD USED TO FUNCTIONALLY TEST FOR ROD DISENGAGEMENT; SAMPLE ROD PROPERLY RETAINED. ADDITIONALLY, LMC/MMC ROD SIMULATION GAGE G0836 USED TO VERIFY PROPER RETENTION. THE MMC CONDITIONS PROPERLY RETAINED; THE LMC GAGE WAS NOT RETAINED. ROD INSERTER ALSO INSPECTED FOR -07 ARC ROD 0.5 MAX GAP DIMENSION AND FOUND TO BE ABOVE PRINT SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE POSTERIOR SPINAL SURGERY. IT WAS REPORTED THAT THE ROD INSERTER WOULD NOT HOLD THE ROD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL NKB MSD BARTLETT MFG NA M06G0108B

    Patients

    Seq Age Sex Outcome Treatment
    1