BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANYPLUS

    MDR report key: 9501360 · Received December 20, 2019

    Report

    Report Number
    3008850074-2019-00002
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    January 5, 2018
    Report Date
    December 2, 2019
    Product Code
    MAX
    PMA / PMN Number
    K111354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GS MEDICAL PEEK BN-PIF CAGE, 28X11X10MM 4 DEGREE, BROKE IN SURGERY AS SURGEON WAS MALLETING THE INSERTER WITH THE CAGE INTO THE DISC SPACE. THE SURGEON GAD TO DIG OUT ALL OF THE PIECES, AND THERE WAS NO CAUSE SUCH AS EXCESSIVE FORCE FOR THE CAGE TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300802 ANYPLUS SPINAL IMPLANT, PRODUCT CODE: MAX MAX 1148-0410 151216197

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention