BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL GUIDE WIRE / PEDICLE SCREW SYSTEM

    MDR report key: 13306432 · Received January 20, 2022

    Report

    Report Number
    13306432
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    September 29, 2021
    Report Date
    January 19, 2022
    Manufacturer
    BIOMET SPINE LLC / ZIMMER BIOMET
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDEWIRES WERE USED TO DIRECT SCREWS INTO THE PROPER LOCATION IN THE PELVIS. UPON ATTEMPTED REMOVAL OF THE GUIDEWIRES, THE THREADED TIPS OF THE GUIDEWIRES ON THE RIGHT AND LEFT SIDE FRACTURED AND WERE RETAINED IN THE PELVIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507766 NITINOL GUIDE WIRE / PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB BIOMET SPINE LLC / ZIMMER BIOMET 14-500360

    Patients

    Seq Age Sex Outcome Treatment
    1 4745 DA Female