BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIONEER SURGICAL TRITIUM 2.7MMX12MM/12PK SCREW

    MDR report key: 4232327 · Received July 10, 2014

    Report

    Report Number
    1833824-2014-00012
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 26, 2014
    Report Date
    July 10, 2014
    Manufacturer
    PIONEER SURGICAL
    Product Code
    HRS
    PMA / PMN Number
    K133785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO REPORTS OF ANY INJURY TO THE PATIENT CAUSED BY THE IMPLANTATION OF THESE DEVICES.

    Description of Event or Problem · 1

    SCREWS THAT HAD NOT BEEN EXPOSED TO THE GAMMA IRRADIATION PROCESS WERE IMPLANTED INTO THE PATIENT ON (B)(6) 2014. THERE WERE NO REPORTED ADVERSE EVENTS WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402697 PIONEER SURGICAL TRITIUM 2.7MMX12MM/12PK SCREW STERNUM PLATE FIXATION SYSTEM SCREW, HRS, HWC, JDQ HRS PIONEER SURGICAL 86-27-12-S12 168952

    Patients

    Seq Age Sex Outcome Treatment
    1