BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFOBACIN BONE CEMENT R 1X40-3

    MDR report key: 24725646 · Received March 30, 2026

    Report

    Report Number
    3006946279-2026-00015
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    November 9, 2025
    Report Date
    April 22, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    UDI-DI
    00887868358388
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UNKNOWN INJURY TO RIGHT FINGERS WAS REPORTED FOLLOWING AN UNKNOWN PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS EVENT WAS PREVIOUSLY INCORRECTLY REPORTED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791421 REFOBACIN BONE CEMENT R 1X40-3 BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. AX39BH3001 00887868358388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other