BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT

    MDR report key: 7275992 · Received February 16, 2018

    Report

    Report Number
    3006946279-2018-00062
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Date of Event
    January 16, 2018
    Report Date
    February 16, 2018
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE : FOREIGN. THE EVENT OCCURRED IN (B)(6). CONCLUSION: AN INVESTIGATION HAS BEEN PERFORMED, CONSISTING OF A DOCUMENTARY REVIEW. AS THE PRODUCT HAS NOT BEEN RETURNED, PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. ACCORDING TO THE AVAILABLE DATA, THE EXACT ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. THIS COMPLAINT IS CLOSED BUT COULD BE REOPENED IF FURTHER INFORMATION IS RECEIVED LATER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE FLUID BAG OF MONOMER COULD NOT BE PERFORATED AFTER SEVERAL ATTEMPTS. MIXING THE CEMENT WAS THEREFORE NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121870 OPTIPAC-S 40 REFOBACIN PLUS BONE CEMENT BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. A707A05200

    Patients

    Seq Age Sex Outcome Treatment
    1