BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER SURGICAL TECHNOLOGY (D.B.A RTI SURGICAL)

    MDR report key: 8051798 · Received November 8, 2018

    Report

    Report Number
    1833824-2018-00035
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 8, 2018
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL
    Product Code
    NKB
    PMA / PMN Number
    K130288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INSPECTION OF THE DEVICE WAS NOT ABLE TO BE COMPLETED BECAUSE THE TIP REMAINS IN THE PATIENT AND THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    IN (B)(6), DURING PLACEMENT OF THE SCREW, IN EXTREMELY HARD BONE, THE TIP OF THE DRIVER BROKE OFF AND IMPLANTED IN THE SCREW IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890863 PIONEER SURGICAL TECHNOLOGY (D.B.A RTI SURGICAL) STREAMLINE MIS, SCREW, INSERTER, THREADED NKB PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL 05-SCREW-INS-THRD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR