BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10023116 · Received May 5, 2020

    Report

    Report Number
    1030489-2020-00492
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Report Date
    May 5, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 54840006545, 510K #K091974 AND UDI #(B)(4) 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: STENOSIS AT L2-4 PROCEDURE INVOLVED: SCREW REMOVAL (PLIF AT L2/3 AND L3/4) POST OP, THE SCREW IMPLANTED AT S1 BROKE. BONE UNION HAS BEEN COMPLETED AT L5/S, IT WAS PLANNED TO PERFORM SCREW REMOVAL ON BOTH SIDES OF S1. THE SCREW AND THE BROKEN PARTS WERE REMOVED IN THE SURGERY OF FUSION FOR EXTENDING TO TREAT SUPERIOR ADJACENT SEGMENT DISEASE. THERE WERE NO COMPLICATIONS TO THE PATIENT AFTER THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487497 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H13J0682

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention