BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8017945 · Received October 30, 2018

    Report

    Report Number
    1030489-2018-01419
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 30, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 5440430, UPN (B)(4) AND 510K # K102555 WAS CLEARED IN THE UNITED STATES. PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC VISUAL AND MICROSCOPIC EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREADS. THIS IS CONSISTENT WITH MISALIGNMENT. 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 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L3/4/5 DUE TO LUMBAR SPINAL CANAL STENOSIS. INTRA-OP, WHILE IMPLANTING THE SET SCREW GOT SLIPPED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859683 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5205289

    Patients

    Seq Age Sex Outcome Treatment
    1