BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMAX DBM PUTTY

    MDR report key: 21152720 · Received January 14, 2025

    Report

    Report Number
    3000215346-2025-00001
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    October 29, 2024
    Report Date
    January 14, 2025
    Manufacturer
    ALLOSOURCE
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    118 LOTS PRODUCED FROM DONOR. 22 ALLOFUSE DBM PUTTY 2.5CC, 46 ALPHAGRAFT DBM PUTTY 2.5CC, 25 BIOMAX DBM PUTTY 2.5CC, 12 CANCELLOUS CHIPS 15CC, 1 CANCELLOUS CHIPS 30CC, 7 CANCELLOUS CRUSHED 15CC, 1 FEMORAL HEAD FZ/I D.4.8CM, 1 PAC TC WEDGE, 2 PUROS CANCELLOUS CRUSHED 1-4MM 5CC, 1 STRYKER DBM PUTTY 2.5CC. ALL IN-HOUSE INVENTORY HAS BEEN QUARANTINED FOR EVALUATION.

    Description of Event or Problem · 0

    XTANT MEDICAL HAS RECEIVED A NOTIFICATION OF A POSSIBLE PATIENT REACTION IN WHICH A BIOMAX GRAFT WAS UTILIZED AS PART OF THE SURGICAL PROCEDURE. APPROXIMATELY 7 WEEKS POST OPERATIVELY, THE PATIENT EXHIBITED A FULL BODY RASH WITH RAISED PLAQUES AFTER A THORACIC DECOMPRESSION FUSION PROCEDURE. ADDITIONAL COMMUNICATIONS WITH THE COMPLAINT SOURCE INDICATED THAT THE PATIENT HAS A FAMILY HISTORY OF TITANIUM SENSITIVITY, AND THAT ALLERGY TESTING WAS BEING PERFORMED. WE DO NOT YET HAVE THE RESULTS OF THE ALLERGY TESTING AVAILABLE, BUT WANTED TO SHARE THE INFORMATION THAT WE HAVE BEEN ABLE TO OBTAIN SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897740 BIOMAX DBM PUTTY DERMINERALIZED BONE MATRIX PUTTY MQV ALLOSOURCE BMX-00002 306136-6530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other