BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1881986 · Received October 12, 2010

    Report

    Report Number
    1030489-2010-01322
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE U.S.; HOWEVER A LIKE DEVICE CATALOG # 869-021, 510K # K040962 WAS CLEARED IN THE U.S. DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR EVALUATION. MACROSCOPIC AND OPTICAL EXAMINATION OF THE RETURNED PORTION OF THE ROD IDENTIFIED WITNESS MARK BELOW THE FRACTURE SURFACE CONSISTENT WITH INSTRUMENT USAGE. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A SHEAR LIP AT THE BASE OF THE FRACTURE, SUGGESTING BEND STRESS OVERLOAD. THE FRACTURE SURFACE WAS SEVERELY DAMAGED; THE UNDAMAGED PORTION OF THE FRACTURE SURFACE REVEALED RIVER LINES, ALSO CONSISTENT WITH BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINAL AT T3-L2, THE FIXATION ROD BROKE WHILE BEING BENT IN THE SURGICAL SITE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWQ WARSAW ORTHOPEDIC INC. NA 0087137W

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR PEDICLE SCREWS| IMPLANT: