BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SPECIALTIES

    MDR report key: 16657676 · Received March 31, 2023

    Report

    Report Number
    3014527682-2023-00004
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 27, 2023
    Report Date
    March 31, 2023
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    MTJ
    UDI-DI
    00848782008247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED: IT WAS BROUGHT TO MY ATTENTION IN THE LAMI PACKS THAT THE BONE WAX IS CONTAMINATED WITH WHAT LOOKS LIKE FIBERGLASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1774420 SURGICAL SPECIALTIES BONE WAX MTJ SURGICAL SPECIALTIES 901 CB04QAO 00848782008247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown