BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG PUTTY AND FIBERGRAFT BG PUTTY GPS

    MDR report key: 16586389 · Received March 21, 2023

    Report

    Report Number
    3011015097-2023-00004
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    January 3, 2023
    Report Date
    March 21, 2023
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    PMA / PMN Number
    K170306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER ON FEBRUARY 22, 2023 THAT THE PRODUCT WAS USED IN TWO SEPARATE SURGERIES (B)(6) 2023 WHERE THE GRAFT SEEPED OUT OF THE VOID AND INTO THE SOFT TISSUES. THERE WERE THREE DIFFERENT DEVICES USED IN THE SURGERIES. THERE ARE NO REVISION SURGERIES PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371038 FIBERGRAFT BG PUTTY AND FIBERGRAFT BG PUTTY GPS RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC. 2201054, 2202163, 2201263

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other