BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL GUIDEWIRE / PEDICLE SCREW SYSTEM

    MDR report key: 13994237 · Received April 4, 2022

    Report

    Report Number
    13994237
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 18, 2022
    Report Date
    March 31, 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

    PATIENT IN OPERATING ROOM (OR) FOR POSTERIOR SPINAL FUSION. DURING THE PROCEDURE, GUIDEWIRES WERE USED TO REACH THE PROPER SCREW POSITIONING IN THE LEFT AND RIGHT POSTERIOR PELVISES. UPON ATTEMPTED REMOVAL OF THE GUIDEWIRE USED FOR THE RIGHT SAI SCREW, A FRAGMENT BROKE OFF AND WAS RETAINED IN THE PELVIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81857 NITINOL GUIDEWIRE / PEDICLE SCREW SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB BIOMET SPINE LLC / ZIMMER BIOMET 14-500360 4931033

    Patients

    Seq Age Sex Outcome Treatment
    1 4015 DA Female