BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 9897082 · Received March 30, 2020

    Report

    Report Number
    9897082
    Event Type
    Malfunction
    Date Received
    March 30, 2020
    Date of Event
    February 12, 2020
    Report Date
    February 25, 2020
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT WAS PUT IN THE PATIENT'S BACK. THE IMPLANT BROKE IN THE PATIENT. THE BROKEN IMPLANT WAS TAKEN OUT ALONG WITH THE OTHER BROKEN PIECES. XRAY WAS TAKEN AFTER TO MAKE SURE THERE WERE NO MORE BROKEN PIECES LEFT IN THE PT. XRAYS TAKEN. BROKEN IMPLANT WAS CHECKED BY (B)(4) REP, WHO CLARIFIED THAT ALL PIECES WERE THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360465 VITALITY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB BIOMET SPINE LLC 730M0024

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA