BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MG OSTEOCRETE

    MDR report key: 24377404 · Received February 18, 2026

    Report

    Report Number
    MW5183990
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 22, 2026
    Report Date
    February 10, 2026
    Manufacturer
    BONE SOLUTIONS INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON 01/22/2026, OUR SALES REPRESENTATIVE REPORTED THAT THE PATIENT DEVELOPED ONGOING PAIN AND SURROUNDING BONE EDEMA AT THE SURGICAL SITE. IT IS ASSUMED THAT THE MG OSTEOCRETE IS HAVING AN EFFECT ON THE PATIENT AFTER BEING IMPLANTED ON (B)(6) 2025. THERE HAVE BEEN NO INSTANCES OF THIS KNOWN TO DATE. THE PATIENT UNDERWENT AN OPEN REVISION SURGERY ON (B)(6) 2026 TO REMOVE THE IMPLANTED MG OSTEOCRETE. DURING THE REVISION PROCEDURE, DR. (B)(6) OBTAINED TISSUE PATHOLOGY SAMPLES FOR MALIGNANCY AND INFECTION WORKUP. THE LABS RESULT ON (B)(6) 2026 STATE THAT CULTURES AND PATHOLOGY ARE ALL NEGATIVE FOR INFECTION BUT DO SHOW INFLAMMATORY CELLS. THE INCIDENT REPORTED IS AN EXPECTED AND FORESEEABLE EFFECT WHICH WAS DESCRIBED IN THE INSTRUCTION FOR USE AND IN THE RISK ASSESSMENT. THE PRECAUTIONS / WARNINGS / POTENTIAL ADVERSE EVENTS IN THE INSTRUCTION FOR USE ALREADY COVER THE OCCURRED EVENT, AND HENCE IT CAN BE CONCLUDED THAT THERE ARE NO CORRECTIVE ACTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445258 MG OSTEOCRETE FILLER, BONE VOID, CALCIUM COMPOUND MQV BONE SOLUTIONS INC. 44-050-00-BSI 74905F

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other| H