BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 9689145 · Received February 10, 2020

    Report

    Report Number
    2027467-2020-00009
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    August 2, 2019
    Report Date
    January 14, 2020
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    NKB
    UDI-DI
    00190376137902
    PMA / PMN Number
    K181677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AT THIS TIME. THE IMPLANTS HAVE NOT BEEN REMOVED FROM THE PATIENT NOR HAS THE IDENTIFYING LOT NUMBER(S) BEEN PROVIDED.

    Description of Event or Problem · 1

    FOLLOW UP POST PKJ REVISION USING INVICTUS OPEN SYSTEM. THE SURGEON OBSERVED SET SCREWS BACK OUT AT SEVERAL LEVELS. CURRENT PLAN IS TO MONITOR PATIENT FOR ANY ADDITIONAL SET SCREW BACK OUTS AND ONLY REVISE IF NECESSARY. THE INVICTUS SPINAL FIXATION SYSTEM WAS IMPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153939 INVICTUS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE INC 15100 00190376137902

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other