BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FACTOR¿ PEPTIDE ENHANCED BONE GRAFT

    MDR report key: 21078897 · Received January 6, 2025

    Report

    Report Number
    21078897
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    November 14, 2024
    Report Date
    December 19, 2024
    Manufacturer
    CERAPEDICS INC.
    Product Code
    NOX
    UDI-DI
    00850001680028
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UNKNOWN WHITE MILKY LIQUID INSIDE THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359859 I-FACTOR¿ PEPTIDE ENHANCED BONE GRAFT FILLER, BONE VOID, SYNTHETIC PEPTIDE NOX CERAPEDICS INC. 700-050 24C1947 00850001680028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown