BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 12735903 · Received November 2, 2021

    Report

    Report Number
    1030489-2021-01338
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Report Date
    November 2, 2021
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT: 8116416 WITH UDI# (B)(4) AND 510(K)# K031888 IS MARKETED 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT THE PATIENT HEARD A SOUND FROM BACK, BUT THE PATIENT SAID THAT SHE HAD NO PROBLEM IN HER LIFE, BUT RECENTLY SHE BECAME TO FEEL PAIN WHEN MOVING, SO REOPERATION WOULD BE PERFORMED THIS TIME. PERHAPS IT'S THE DUALROD, THE CONNECTOR WAS BROKEN ( PROBABLY BE X10), AND THE ANTERIOR LENGTHENING WAS SUNK ( THERE IS ONLY A HISTORY OF MOSS MESH, BUT THE PHYSICIAN HAD SAID THAT THIS PRODUCT WAS REMOVED AND REPLACED. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO MALFUNCTION ASSOCIATED WITH SET SCREW (5530230).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1633522 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP G8116416 0435365W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention