BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINAL FIXATION SCREWS

    MDR report key: 20609910 · Received November 4, 2024

    Report

    Report Number
    MW5162135
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    February 1, 2020
    Report Date
    November 4, 2024
    Manufacturer
    BIOME SPINE / HIGHRIDGE MEDICAL, LLC.
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE WAS IMPLANTED WITH A BIOMET SPINE RODS AND SCREWS AND THE SCREWS ARE PULLING OUT. REF REPORTS: MW5162133, MW5162134.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460686 BIOMET SPINAL FIXATION SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB BIOME SPINE / HIGHRIDGE MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention