BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER SURGICAL TECHNOLOGY CONTRACT ANTERIOR LUMBAR PLATE SCREW TIGHTENER

    MDR report key: 6219961 · Received January 3, 2017

    Report

    Report Number
    1833824-2017-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2017
    Date of Event
    December 8, 2016
    Report Date
    January 3, 2017
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
    Product Code
    LXH
    PMA / PMN Number
    K090222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WITHOUT PART OF THE TIP WAS RETURNED TO PIONEER SURGICAL TECHNOLOGY. THIS RETURNED PORTION OF THE DEVICE WAS INSPECTED AND FOUND TO BE WITHIN SPECIFICATIONS FOR HARDNESS. SINCE THE BROKEN PART OF THE TIP REMAINS IN THE PATIENT AND WAS NOT RETURNED FOR EVALUATION NO FURTHER INVESTIGATION COULD BE DONE. THE DHR FOR THIS DEVICE WAS REVIEWED AND IT WAS FOUND TO BE MANUFACTURED TO PIONEER SURGICAL TECHNOLOGY SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING AN ANTERIOR LUMBAR SPINAL FUSION SURGERY THE TIP OF THE SCREW TIGHTENER BROKE OFF AND REMAINS IN THE PATIENT. THIS RESULTED IN NO NEGATIVE EFFECT ON THE PATIENT AND SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2953 PIONEER SURGICAL TECHNOLOGY CONTRACT ANTERIOR LUMBAR PLATE SCREW TIGHTENER ANTERIOR LUMBAR PLATE SCREW TIGHTENER LXH PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) 25-TIGHTENER 066923

    Patients

    Seq Age Sex Outcome Treatment
    1