BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG PUTTY

    MDR report key: 19073381 · Received April 9, 2024

    Report

    Report Number
    3011015097-2024-00003
    Event Type
    Injury
    Date Received
    April 9, 2024
    Report Date
    April 9, 2024
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    PMA / PMN Number
    K170306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AFTER A REVIEW OF THE JOURNAL ARTICLE (SAMADE, R. ET AL (2022), UTILITY OF 45S5 BIOACTIVE GLASS AS BONE GRAFT SUBSTITUTE FOR CAVITARY DEFECTS IN PEDIATRIC BONE TUMORS: A PRELIMINARY STUDY, J PEDIATR ORTHOP VOL. 42 (9), PAGES 532-538 (USA)), IT WAS REPORTED TO THE MANUFACTURER ON MARCH 12, 2024 THAT ONE OF THE 21 PATIENTS DEVELOPED A SURGICAL SITE INFECTION AFTER TREATMENT OF AN ANEURYSMAL BONE CYST. NO ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE ADVERSE EVENT. THERE IS NO EVIDENCE THAT THE INFECTION WAS DUE TO THE PRODUCT, BUT THIS COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287714 FIBERGRAFT BG PUTTY RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other