BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3063282 · Received April 17, 2013

    Report

    Report Number
    1030489-2013-01079
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL COMPARISON OF MAS AND FAS TO COMPARISON SAMPLE DID NOT IDENTIFY MATERIAL DIFFERENCE WITH THREADS. MAJOR DIAMETER AND BONE SCREW LENGTH FOUND TO BE CONSISTENT WITH PRINT SPECIFICATION. UNABLE TO REPLICATE CUSTOMER CONCERN; AFTER VISUAL, OPTICAL AND DIMENSIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE IMPLANTS APPEAR TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    'IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE AT L4-S (L4-L5 VIA PLF, L5-S PLIF USING COMPETITOR'S SPINAL CAGE) TO TREAT L5-S SPONDYLOLISTHESIS. IT WAS REPORTED THAT DURING APPLYING REDUCTION FORCES AT L5 THE LEFT L5 SCREW WAS EXTRACTED FROM THE PEDICLE. A SCREW WAS REINSERTED IN THE LEFT L5 PEDICLE. INTRA-OP IMAGES SHOWED THE TIP OF THE SCREW WAS OUTSIDE OF THE VERTEBRA, SO THAT THE SCREW WAS REMOVED AFTER UNTIGHTENING THE LEFT SETSCREWS. NO PATIENT COMPLICATIONS WERE REPORTED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164229 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA

    Patients

    Seq Age Sex Outcome Treatment
    1