BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG MATRIX, 12.5CC

    MDR report key: 16454597 · Received February 28, 2023

    Report

    Report Number
    3011015097-2023-00003
    Event Type
    Injury
    Date Received
    February 28, 2023
    Date of Event
    July 8, 2022
    Report Date
    February 28, 2023
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    UDI-DI
    00856879006151
    PMA / PMN Number
    K180080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2023 THAT THE PRODUCT WAS IMPLANTED IN THE LATERAL GUTTERS IN THE PATIENT ON A T8-ILIUM POSTERIOR FUSION ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT PRESENTED WITH A SEVERE INFECTION IN THE POSTERIOR LATERAL GUTTERS. THE SURGEON REMVOED ALL THE PRODUCT IN THE POSTERIOR LATERAL GUTTERS AND WASHED OUT THE AREA. THE PATIENT WAS BROUGHT BACK FOR WASH OUT TWO MORE TIMES, ON (B)(6) 2022 AND (B)(6) 2022. ALL THE SCREWS, RODS, AND SET SCREWS IMPLANTED ALONG WITH THE PRODUCT ON (B)(6) 2022 REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856550 FIBERGRAFT BG MATRIX, 12.5CC RESORBABLY CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC. 5500-0125 00856879006151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention