BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON

    MDR report key: 5313159 · Received December 21, 2015

    Report

    Report Number
    1030489-2015-03516
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 26, 2015
    Report Date
    November 27, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: X-RAY ANALYSIS:THE PATIENT HAS A REVISION SURGERY TO A L4-5 TLIF BECAUSE OF AN L3 VERTEBRAL FRACTURE.POST OP X-RAYS ARE PROVIDED THAT SHOW A FRACTURED AXIAL CONNECTOR AT L2-3 BUT THE LEVELS ARE DIFFICULT TO COUNT ON X-RAYS PROVIDED. IT IS UNCLEAR WHY A CONNECTOR WAS USED IN THIS SURGERY BUT IT WAS PLACED AT THE DEFORMITY APEX.THIS IS A POSSIBLE REASON OF FAILURE.IT IS ALSO UNCLEAR HOW AFTER REVISION SURGERY THIS OCCURED.UNABLE TO ASSESS PRESENCE OF BONY FUSION.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# G84505HT AND 510 K NUMBER K981676 IS APPROVED IN US. (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIAL SURGERY HAPPENED ON (B)(6) 2013 (TLIF:L3/5/S LEVELS) AND REVISION SURGERY HAPPENED ON (B)(6) 2015 DUE TO FRACTURE OF VERTEBRAL BODY AT L3. IN THIS REVISION SURGERY, RODS WERE CONNECTED WITH AXIAL CONNECTOR BETWEEN L1 AND L2 AND ALSO ON OTHER SIDE(SIDE WHERE AXIAL CONNECTOR WAS FOUND BROKEN). AFTER THIS REVISION SURGERY PATIENT VISITED HOSPITAL FOR ROUTINE VISIT WHERE PATIENT UNDERWENT X-RAY IN WHICH IT WAS FOUND THAT AXIAL CONNECTOR WAS FOUND BROKEN. PATIENT HAS NO COMPLAINT OF PAIN AND NO SURGERY IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842281 CD HORIZON APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1