BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10894499 · Received November 24, 2020

    Report

    Report Number
    1030489-2020-01682
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Report Date
    November 24, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT MARKETED IN US. 510(K) FOR SIMILAR DEVICE MARKETED IN US WITH CATALOGUE#75447545 IS K042025. 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 VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF COLLAPSE OF L3. IT WAS REVISION SURGERY. IN THE INITIAL SURGERY ON (B)(6) 2019, POSTERIOR FUSION WAS PERFORMED AT L2-5 DUE TO THE COLLAPSE OF L3.THEN ON AUG 3,2019, FUSION FOR EXTENDING WAS PERFORMED BETWEEN S1 AND IL. AFTER THAT, REMOVAL WAS PERFORMED AT L2, L5 AND S1, AND TWO SCREWS WERE INSERTED ADDITIONALLY ON EACH SIDE OF IL ON (B)(6) 2019. IN THIS SURGERY DONE ON (B)(6) 2020, REMOVAL WAS PERFORMED AT L3, AND SCREW WAS INSERTED ADDITIONALLY AT T12, L1, L2 AND L3 TO CONNECT AND FUSION FOR EXTENDING WAS PERFORMED DUE TO THE COLLAPSE OF L1.THERE WAS HEALTH DAMAGE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359337 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G75447545 H5517991

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention