BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10205527 · Received June 29, 2020

    Report

    Report Number
    1030489-2020-00743
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Report Date
    June 29, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    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

    BACK PAIN: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE WITH CATALOG # 55811015540, UPN# 00643169065314 AND 510K # K122433 WAS CLEARED IN THE UNITED STATES. 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 OP DIAGNOSIS: SPINAL CANAL STENOSIS PROCEDURE PERFORMED: REMOVAL OF L1 SCREW AND FUSION FOR EXTENDING UP TO T10. POST OP, SCREW ON THE RIGHT AND LEFT SIDE OF L1 WERE LOOSEN. PATIENT SUFFERED BACK PAIN DUE TO SCREW LOOSENING. PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672796 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5546452

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O