BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATURE LORDOTIC IMPLANT

    MDR report key: 1850102 · Received September 24, 2010

    Report

    Report Number
    3003855635-2010-00009
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    MQP
    PMA / PMN Number
    K091406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR THE SUBJECT LOT WAS REVIEWED AND NO ANOMALIES OR NON-CONFORMANCES WERE FOUND IN THE RECORDS THAT COULD HAVE CONTRIBUTED TO THE DEVICE FAILURE. THE EXAMINATION OF THE BROKEN IMPLANT SHOWED NO INDICATION OF POSSIBLE MIS-THREADING OR STRIPPED THREADS TO THE HALO WHICH MATES TO THE INSERTION TOOL. ACCORDINGLY NO CONCLUSION CAN BE MADE BASED ON THE CURRENTLY KNOWN INFORMATION.

    Description of Event or Problem · 1

    DOCTOR WAS INSERTING THE IMPLANT, WHILE BEING TWISTED IN PLACE, IT BROKE. THE DOCTOR REMOVED THE IMPLANT WITHOUT INCIDENT. THERE WAS NO INJURY OR HARM TO THE PATIENT, AND A NEW IMPLANT WAS INSERTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention