BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS PLS

    MDR report key: 2045684 · Received February 28, 2011

    Report

    Report Number
    2032499-2011-00063
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    October 24, 2008
    Report Date
    November 12, 2008
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    MRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: DUE TO THE SPINOUS PROCESS BEING IN THE WAY, THE DRILL WAS MOVED OFF ANGLE WHILE DRILLING THE HOLE. EXCESSIVE PRESSIVE PLACED ON K-WIRE. INITIALLY IT WAS DETERMINED THE EVENT WAS NOT REPORTABLE. ON A SUBSEQUENT RE-REVIEW, IT WAS DETERMINED THIS EVENT SHOULD HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    K-WIRE USED IN THE SURGERY BROKE IN THE PATIENT'S SACRUM. BROKEN PIECE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS PLS MRW INTERVENTIONAL SPINE, INC. 9045-01 030708-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention