BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9539936 · Received January 2, 2020

    Report

    Report Number
    1030489-2020-00011
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    November 8, 2019
    Report Date
    January 2, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    UDI-DI
    00721902729331
    PMA / PMN Number
    K030840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED AS PER MEDWATCH (REPORT # 5091192) THAT THE PATIENT UNDERWENT FUSION AND LAMINECTOMY/FACETECTOMY. INTRA-OP, WHILE INSERTING A SET SCREW FOR ATTACHING THE CROSSLINK, A SCREW BROKE. THE SURGEON WAS ABLE TO RETRIEVE ALL THE PIECES OF THE BROKEN SCREW; AND A NEW SCREW WAS USED TO SECURE THE CROSSLINK. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK 00721902729331

    Patients

    Seq Age Sex Outcome Treatment
    1