BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE POSITION LORDOTIC SPACER

    MDR report key: 2632068 · Received May 16, 2012

    Report

    Report Number
    3003855635-2012-00003
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 15, 2012
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    MAX
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANOMALIES NOTED WITH SIMILAR DEVICE OR REVIEW OF DHR RECORDS. CAUSE OF EXPULSION UNK.

    Description of Event or Problem · 1

    MFR WAS NOTIFIED VIA A PHONE CALL FROM SURGEON THAT AN IMPLANT HAD EXPULSED POSTERIORLY INTO THE CANAL. SURGEON SUBSEQUENTLY FORWARDED X-RAY IMAGES. SURGEON INFORMED MFR THAT THE REVISION SURGERY WOULD OCCUR ON (B)(6) 2012 AND THAT THE PT WAS ASYMPTOMATIC AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUE POSITION LORDOTIC SPACER ATLAS SPINE PIVOTING SYSTEM MAX ATLAS SPINE INC. 70217-027-009 01415

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention