BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10821455 · Received November 11, 2020

    Report

    Report Number
    1030489-2020-01627
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Report Date
    November 11, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT MARKETED IN US. 510K NO. FOR SIMILAR PRODUCT MARKETED IN U.S. WITH CATALOGUE #: 9690025 IS K043488. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT THAT OCCURRED DURING A SPINAL FUSION PROCEDURE FOR A PATIENT DIAGNOSED WITH DEGENERATIVE KYPHOSCOLIOSIS. IT WAS REPORTED THAT THE ROD BROKE DURING USE. A RE-OPERATION WAS PERFORMED ON (B)(6) 2020 TO EXPLANT THE ROD, AND ITS FRAGMENTS. THE REASON FOR BREAKING OF ROD, AS THE BONE FUSION WAS ACHIEVED, WAS UNKNOWN. IN REOPERATION THE BROKEN ROD WAS REPLACED, AND BY MRC THE ROD WAS ADDED INSIDE, RE-FUSION WAS PERFORMED WITH 4 RODS. THE REMOVED ROD WAS DISCARDED BY MEDICAL INSTRUMENT, IT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290330 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1606300500 0388330W

    Patients

    Seq Age Sex Outcome Treatment
    1