BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APELO

    MDR report key: 5054136 · Received September 3, 2015

    Report

    Report Number
    3003855635-2015-00003
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 6, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K110842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED PHONE CALL REQUESTING INSTRUMENTATION FOR A REVISION SURGERY. PREVIOUS SURGERY HAD SUCCESSFULLY FUSED AT L5/S1 BUT PATIENT WAS NOW SYMPTOMATIC AT L4/L5. REP NOTED THAT THE S1 SCREW WAS FRACTURED BASED ON IMAGING BUT WAS NOT THE REASON FOR THE REVISION SURGERY. PATIENT WAS FUSED AT THE L5/S1 LEVEL BUT CLINICAL NEED EXISTS TO EXTEND UP TO L4/L5 UNRELATED TO THE BROKEN SCREW. SURGEON NOTED THAT THE IMPLANT WOULD'VE BEEN LEFT ALONE IF NOT FOR NEED TO EXTEND UP LEVEL DUE TO PAIN AT AN ADJACENT LEVEL. REVISION SURGERY WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585614 APELO PEDICLE SCREW SYSTEM MNI ATLAS SPINE, INC. 11087-065-035 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention