BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8968894 · Received September 6, 2019

    Report

    Report Number
    1030489-2019-00989
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 6, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE MARKET, HOWEVER, A LIKE DEVICE WITH PART# 55811015545, 510K# K122433 AND UDI (B)(4) IS AVAILABLE FOR THE MARKET USE. 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 FIXATION AT T12-L2 DUE TO L1 BURST FRACTURE. POST-OP, AN EXPLOSIVE SOUND WAS HEARD DURING REHABILITATION. WHEN X-RAY WAS PERFORMED, IT WAS FOUND THAT THE SCREW ON THE RIGHT OF L2 BROKE. THE BREAKAGE OCCURRED FROM THE BASE OF THE SCREW HEAD OF THE SCREW WHICH WAS ON THE RIGHT OF L2, AND THE SCREW HEAD AND THE ROD WERE IN A UNSTABLE STATE. HENCE, A REVISION SURGERY WAS PERFORMED AND THE BROKEN SCREW WAS REMOVED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762035 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA15B091

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention