BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9892555 · Received March 28, 2020

    Report

    Report Number
    1030489-2020-00388
    Event Type
    Malfunction
    Date Received
    March 28, 2020
    Report Date
    March 28, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG # 1476000500, 510K # K091974, UDI#: (B)(4) IS APPROVED FOR SALE IN THE US. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: IMPLANT REMOVAL DUE TO ROD BREAKAGE PROCEDURE PERFORMED: FIXATION AFTER VERTEBRAL BODY FRACTURE LEVELS IMPLANTED: L1-5 POST-OP, THE IMPLANT REMOVAL WAS PERFORMED BECAUSE ROD WAS BROKEN. AS BONE UNION HAD BEEN ACHIEVED IMPLANT REMOVAL WAS PERFORMED WITHOUT REINSERTING THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357753 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0588002W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention