BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APELO PEDICLE SCREW SYSTEM, INTRASPINAL - 024

    MDR report key: 2509217 · Received March 27, 2012

    Report

    Report Number
    3003855635-2012-00002
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 27, 2012
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECEIVED REQUEST FROM REPRESENTATIVE THAT SURGEON WOULD LIKE THE CHIEF TECHNICAL OFFICER TO REVIEW SOME X-RAYS. UPON REVIEW CHIEF TECHNICAL OFFICER INDICATED THAT THE POLY HEAD MAY BE DISLOCATED FROM THE SCREW SHANK. DURING SUBSEQUENT REVISION SURGERY, IT WAS CONCLUDED THAT THE L2 LEFT POLY REDUCTION HEAD WAS NOT ENGAGED ONTO THE SCREW SHANK AND THAT THE L5 RIGHT PEDICLE SCREW HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APELO PEDICLE SCREW SYSTEM, INTRASPINAL - 024 NONE KWQ ATLAS SPINE, INC. 70026 01546

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention