BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFOBACIN BONE CEMENT R

    MDR report key: 7279641 · Received February 19, 2018

    Report

    Report Number
    3006946279-2018-00064
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 15, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). REPORT SOURCE, FOREIGN- EVENT OCCURED IN (B)(6). AN INVESTIGATION HAS BEEN PERFORMED, CONSISTING OF A DOCUMENTARY REVIEW. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 CONSECUTIVE MIXTURES OF OPTIPAC 40 WERE PERFORMED, AND THEY DID NOT FUNCTION AS INTENDED. THE MONOMER DID NOT ENTER THE CYLINDER. ON THE THIRD ATTEMPT IT WORKED AS INTENDED. THERE WAS NO PATIENT INJURY AND NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123468 REFOBACIN BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A633A04240

    Patients

    Seq Age Sex Outcome Treatment
    1