BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8013448 · Received October 29, 2018

    Report

    Report Number
    1030489-2018-01417
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    June 20, 2018
    Report Date
    October 29, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 54840016550, 510K# K091974 AND (B)(4) IS APPROVED FOR SALE IN US. PRODUCT ANALYSIS RESULT: VISUAL FUNCTIONAL THERE ARE VISUAL SIGNS OF DAMAGE TO THE LEADING EDGE OF THE THREADS ON BONE SCREW HEAD. THE REMINDING PORTION OF THE THREADS DO NOT APPEAR TO BE DAMAGED. THIS TYPE OF DAMAGE IS CONSISTENT WITH MISALIGNMENT BETWEEN THE BONE SCREW HEAD AND THE BREAK OFF SCREW. 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, THE THREADS OF THE SCREW WAS FOUND DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853105 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H5355766

    Patients

    Seq Age Sex Outcome Treatment
    1