BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEVIEW ACPS

    MDR report key: 1470708 · Received June 12, 2009

    Report

    Report Number
    3003855635-2009-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2009
    Date of Event
    May 21, 2009
    Report Date
    June 13, 2009
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K050588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER, SPOKE WITH THE SALES REPRESENTATIVE, WHO WAS PRESENT IN SURGERY. THE REP SAID THAT HE NOTICED THE O.R. TECH PICK UP THE VERTEVIEW PLATE BY PINCHING THE ENDS BETWEEN HIS FINGERS WHEN HE WAS CARRYING IT TO THE SURGEON. HE BELIEVED THAT THE O.R. TECH INADVERTENTLY ENGAGED ONE OR BOTH OF THE END LOCKING TABS AS HE CARRIED THE PLATE TO THE SURGEON. HE TOLD HIS THEORY TO THE SURGEON AFTER THE CASE WAS FINISHED AND THE SURGEON AGREED THAT THIS THEORY WAS PROBABLY CORRECT. NO ADDITIONAL INFO CAN BE OBTAIN SINCE THE SALES REPRESENTATIVE HAS TERMINATED HIS EMPLOYMENT.

    Description of Event or Problem · 1

    DOCTOR ATTEMPTED TO SET THE PLATE AND WHEN THE SCREW WAS INTRODUCED THE LOCKING MECHANISM ENGAGED BEFORE THE SCREW WAS COMPLETELY SET. AT THAT POINT, THE DOCTOR ABANDONED THE SYSTEM AND USED SOMETHING ELSE TO FINISH HIS CASE. SURGERY DELAYED APPROX 20-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEVIEW ACPS SPINAL INTERVERTEBRAL BODY FIXATION ORT KWQ ATLAS SPINE INC. 00578

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention