BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX PEEK INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 20609893 · Received November 4, 2024

    Report

    Report Number
    MW5162133
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    February 1, 2020
    Report Date
    November 4, 2024
    Manufacturer
    LANX / HIGHRIDGE MEDICAL, LLC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CALLER STATED THAT SHE JUST FOUND OUT THAT THERE IS NICKLE IN THE LANX PEEK FUSION DEVICE THAT WAS IMPLANTED IN HER AND SHE IS ALLERGIC TO NICKLE. REF REPORTS: MW5162134, MW5162135.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429774 LANX PEEK INTERVERTEBRAL BODY FUSION DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX LANX / HIGHRIDGE MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention