BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG PUTTY GPS, 6CC, CE

    MDR report key: 16368899 · Received February 13, 2023

    Report

    Report Number
    3011015097-2023-00002
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    August 13, 2022
    Report Date
    February 13, 2023
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    UDI-DI
    00856879006366
    PMA / PMN Number
    K170306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER ON JANUARY 30, 2023 THAT THE SURGEON COMPLETED A REVISION SINCE THE PATIENT WAS EXPERIENCING A NEW ONSET OF NUMBNESS IN LEG DUE TO THE DISLOCATED PRODUCT. THE PATIENT IS NOW SYMPTOM-FREE AGAIN. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THIS EVENT SHOULD BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516921 FIBERGRAFT BG PUTTY GPS, 6CC, CE RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC. 2109231 00856879006366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention