BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5976213 · Received September 26, 2016

    Report

    Report Number
    1030489-2016-02649
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 8115536 AND 510K# K030840 IS APPROVED FOR SALE IN US. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    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 PATIENT UNDERWENT POSTERIOR FUSION AT T11-L4. POSTOPERATIVELY RADICULOPATHY WAS OBSERVED AT RIGHT L3 FOR WHICH PATIENT UNDERWENT SURGERY. DURING REVISION SURGERY, WHEN THE SET SCREW AT CAUDAL CROSSLINK WAS BEING REMOVED, ONE OF THE SET SCREW STRIPPED. IT WAS REMOVED ALONG WITH THE ROD AND WAS DISCARDED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627937 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0455158W

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR