BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER SURGICAL RELEASE LAMINOPLASTY FIXATION SYSTEM, STEAM STERILIZATION CASE

    MDR report key: 6037685 · Received October 18, 2016

    Report

    Report Number
    1833824-2016-00035
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 19, 2016
    Report Date
    October 18, 2016
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY (D.B.A.RTI SURGICAL)
    Product Code
    LRP
    PMA / PMN Number
    K153735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STEAM STERILIZATION CASE WAS RETURNED TO PIONEER SURGICAL TECHNOLOGY AND THE LATCHES THAT HOLD THE CASE LID IN PLACE WERE VERY DIFFICULT TO OPEN AND CLOSE. THE DHR WAS REVIEWED AND THIS CASE WAS MADE TO PIONEER SURGICAL TECHNOLOGIES SPECIFICATIONS. THERE HAVE BEEN NO REPORTED INJURIES CAUSED BY THIS STEAM STERILIZATION CASE BUT SINCE THERE IS A REMOTE POTENTIAL THAT BY OPENING THE LID THE USER MAY TEAR THEIR GLOVE AND/OR HAND PIONEER SURGICAL TECHNOLOGY IS REPORTING THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING A LAB DEMONSTRATION IT WAS OBSERVED BY A RTI SURGICAL ASSOCIATE PRODUCT MANAGER THAT THE LID ON THE STEAM STERILIZATION KIT WAS DIFFICULT TO REMOVE AND HAS A POTENTIAL OF RIPPING A GLOVE IF IT WAS USED IN A CLINICAL SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687943 PIONEER SURGICAL RELEASE LAMINOPLASTY FIXATION SYSTEM, STEAM STERILIZATION CASE STEAM STERILIZATION CASE LRP PIONEER SURGICAL TECHNOLOGY (D.B.A.RTI SURGICAL) 434-222 47140

    Patients

    Seq Age Sex Outcome Treatment
    1