BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8786623 · Received July 12, 2019

    Report

    Report Number
    1030489-2019-00756
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 12, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 1606200500, 510K# K131321 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. 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 THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT POSTERIOR CORRECTION FIXATION AT T10-S2AI DUE TO ADULT DEFORMITY. ONE YEAR POST-OP, THE ROD USED IN THE OPERATION BROKE ON ONE SIDE AT L4-L5 LEVEL. THE PRODUCT REMAINS IMPLANTED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED; HENCE, THERE IS NO PLAN FOR ANY REVISION SURGERY YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578781 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1