BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATURE PEEK SPACER

    MDR report key: 1659672 · Received April 14, 2010

    Report

    Report Number
    3003855635-2010-00006
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    March 10, 2010
    Report Date
    April 8, 2010
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    MQP
    PMA / PMN Number
    K091406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW SHOWED NO ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. EVENT CONSIDERED AN ISOLATED INCIDENT. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE DOCTOR INSERTED THE IMPLANT INTO THE PREPARED SITE AND TAPPED THE INSERTER HANDLE WITH A MALLET TO THE DESIRED DEPTH. ROTATING CLOCKWISE, THE HANDLE POPPED AND ROTATED FREELY. UNDER MICROSCOPE, THE IMPLANT HAD ROTATED, AND THE ATTACHMENT POINT OF THE IMPLANT WAS DEFORMED. THE DOCTOR ACCEPTED THE RESULTS LEAVING THE IMPLANT IN THE PT, SURGERY COMPLETED WITH NO FURTHER COMPLICATIONS. DOCTOR LATER COMMENTED THAT HE THOUGHT THE IMPLANT WAS INCORRECTLY LOADED ON TO THE INSERTER BY THE SURGICAL TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STATURE PEEK SPACER LUMBAR IBFD MQP ATLAS SPINE INC. 00702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention