BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8361066 · Received February 22, 2019

    Report

    Report Number
    1030489-2019-00181
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 22, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    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

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 55811015550, 510K# K122433, AND UPN (B)(4) IS APPROVED FOR MARKET IN THE 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR FUSION AT TH11/TH12 LEVELS AND UNDERWENT IMPLANT REMOVAL. DURING THE REVISION SURGERY TO PERFORM IMPLANT REMOVAL, BREAKAGE OCCURRED BETWEEN SCREW HEAD AND SCREW PITCH. THE SCREW PITCH PORTION OF THE ALLEGED PRODUCT AT LEFT AND RIGHT OF L5 COULD NOT BE REMOVED, AND REMAINED. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF ALLEGED EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154127 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA15L026

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention