BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANTERIOR INSERTION RAMP

    MDR report key: 15178346 · Received August 5, 2022

    Report

    Report Number
    3004774118-2022-00316
    Event Type
    Malfunction
    Date Received
    August 5, 2022
    Date of Event
    July 11, 2022
    Report Date
    November 4, 2022
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    UDI-DI
    10888857025448
    PMA / PMN Number
    K133614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODES HAVE BEEN UPDATED TO REFLECT RECEIPT OF THE DEVICE AND CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANTERIOR LUMBAR DISC PREP MODULAR ANTERIOR INSERTION RAMP AND INNER SHAFT ASSEMBLY WAS TURNING ON INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE MODULAR ANTERIOR INSERTION RAMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ANTERIOR LUMBAR DISC PREP MODULAR ANTERIOR INSERTION RAMP AND INNER SHAFT ASSEMBLY WAS TURNING ON INSERTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE MODULAR ANTERIOR INSERTION RAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274903 MODULAR ANTERIOR INSERTION RAMP INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX K2M, INC. 2008-90018 PKPR 10888857025448

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown