BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATURE VBR

    MDR report key: 1574003 · Received December 22, 2009

    Report

    Report Number
    3003855635-2009-00010
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    November 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K063205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CLARIFICATION OF THE REPORTED EVENT HAS BEEN REQUESTED FROM THE SURGEON. IF MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. METHOD(S), RESULT(S) AND CONCLUSION(S) WILL BE MADE AVAILABLE IN A SUPPLEMENTAL REPORT FOLLOWING COMPLETED EVALUATION.

    Description of Event or Problem · 1

    DURING THE SAME SURGERY, AS DOCTOR INSERTED AND ROTATED EACH IMPLANT, THREE IMPLANTS CRACKED DURING PLACEMENT. SURGERY COMPLETED WITH FOURTH IMPLANT [SAME SIZE, SAME LOT NUMBER] WITHOUT ANY FURTHER COMPLICATIONS TO THE PATIENT EXCEPT FOR DELAY OF SURGERY. THIS IS THE FIRST OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATURE VBR VERTEBRAL BODY REPLACEMENT MQP ATLAS SPINE, INC. 00638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention