BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6649438 · Received June 19, 2017

    Report

    Report Number
    1030489-2017-01585
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 25, 2017
    Report Date
    August 24, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    VISUAL AND OPTICAL EXAMINATION OF THE SAS IDENTIFIED AXIAL SURFACE WEAR ON THE -03 SADDLE COMPONENT, CONSISTENT WITH SET SCREW BACKOUT AND SUBSEQUENT AXIAL CYCLIC MOVEMENT OF THE ROD. SIMILAR WEAR MARKS ARE ALSO NOTED ON CORRESPONDING LOCATION OF ROD OD SURFACE. MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST/FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED NEAR THE START OF THE THREAD, AND IS EVIDENT AROUND THE DAMAGED PORTION OF THE THREAD. FUNCTIONAL EVALUATION WITH A SAMPLE MAS HEAD FOUND THE SET SCREW WAS UNABLE TO BE FULLY ENGAGED. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE SAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY. THE THREAD MISALIGNMENT APPEARS TO HAVE PREVENT FULL SEATING OF THE SET SCREW, THUS ALLOWING SET SCREW BACKOUT, AND CONTRIBUTING TO WEAR OF SAS SADDLE AND ROD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER, A LIKE DEVICE WITH PART# 55811017545, 510K# K122433 AND UPN (B)(4) IS MARKETED IN THE US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS( INITIAL SURGERY): L1 BURST FRACTURE. PROCEDURE: POSTERIOR SPINAL FUSION LEVELS INVOLVED: T12-L2. IT WAS REPORTED THAT DURING A REVISION POST BONE UNION, METALLOSIS WAS FOUND WHILE REMOVING THE SCREWS AT THE RIGHT OF L2. SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430687 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA CA15B117

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR