BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    06.5MM ISSYS PEDICLE SCREW SYSTEM

    MDR report key: 730919 · Received June 22, 2006

    Report

    Report Number
    3005129649-2006-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2006
    Date of Event
    May 22, 2006
    Report Date
    June 19, 2006
    Manufacturer
    CUSTOM SPINE, INC.
    Product Code
    MCV
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SPEAKING WITH THE SURGEON, THERE IS NO CONCLUSION TO THE CAUSE OF THE PROBLEM. IT MAY BE A SUSPECTED IMPLANT MALFUNCTION OR IT COULD BE DUE TO USER ERROR. THE OTHER 7 BLOCKERS 013000 USED IN THE SURGERY HAD NO FAILURES SO THE INSTRUMENTATION APPEARS TO BE WORKING AS INTENDED EXCEPT FOR THE SINGLE DISASSEMBLED BLOCKER. THE PRODUCT WAS NOT RETURNED AND THE EXACT SIZES AND LOT NUMBERS WERE NOT NOTED BY THE USER. ONLY X-RAY EVALUATION WAS POSSIBLE. THIS IS THE FIRST OCCURANCE OF THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    A BLOCKER CAT # 013000 WAS SEPARATED FROM AN ISSYS PEDICLE SCREW CAT # 0165XX (06.5MM, UNKNOWN LENGTH). THIS WAS OBSERVED BY THE SURGEON AT THREE MONTHS FOLLOW-UP. THE PATIENT IS ASYMPTOMATIC WITH INTACT FUSION. THE SURGEON IS NOT INTERVENING AND THERE WERE NO OUTCOMES ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 06.5MM ISSYS PEDICLE SCREW SYSTEM PEDICLE SCREW MCV CUSTOM SPINE, INC. * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR