BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9858501 · Received March 20, 2020

    Report

    Report Number
    1030489-2020-00334
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Report Date
    March 20, 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

    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

    PRE-OPERATIVE DIAGNOSIS: ROD BREAKAGE PROCEDURE PERFORMED: POSTERIOR SPINAL FUSION (PSF) LEVELS IMPLANTED: T10-S2AI POST-OP, THE ROD WAS BROKE OFF AROUND L4/5 UNDER LPC ON THE LEFT SIDE. ACCORDING TO SURGEON AUTOLOGOUS BONE GRAFT FOR THE ANTERIOR SIDE WAS PERFORMED AROUND L5 IT HAD BECOME PSEUDOARTHROSIS. IN THE REVISION SURGERY THE BROKEN PART OF THE ROD, FOUR CONNECTORS (FROM OTHER MANUFACTURER) WERE PLACED AND 6.0CO-CR ROD WAS CUT AND PLACED AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325894 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0325770W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention