BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG PUTTY

    MDR report key: 19087026 · Received April 11, 2024

    Report

    Report Number
    3011015097-2024-00004
    Event Type
    Injury
    Date Received
    April 11, 2024
    Report Date
    April 11, 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 BY MEDICAL AFFAIRS, (VICENTI, G., ET. AL., (2022), USE OF THE 95-DEGREE ANGLED BLADE PLATE WITH BIOLOGICAL AND MECHANICAL AUGMENTATION TO TREAT PROXIMAL FEMUR NON-UNIONS: A CASE SERIES, BMC MUSCULOSKELETAL DISORDERS, VOL.22 (XX) PAGES 1-11, (ITALY)), IT WAS REPORTED TO THE MANUFACTURER ON MARCH 12, 2024 THAT ONE OF THE FIFTEEN PATIENTS HAD WOUND DEHISCENCE, WHICH WAS TREATED WITH A SUPERFICIAL SURGICAL DEBRIDEMENT. IT WAS STATED IN THE STUDY THAT THE PRODUCT WAS USED IN TWO OF THE FIFTEEN PATIENTS. IT WAS NOT CONFIRMED WHETHER THE PATIENT THAT EXPERIENCED THE WOUND DEHISCENCE WAS ONE OF THE PATIENTS THAT RECEIVED THE PRODUCT SO IT IS UNKNOWN IF THE PRODUCT WAS INVOLVED, BUT THE COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683303 FIBERGRAFT BG PUTTY RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other