BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIPAC 60 REFOBACIN® BONE CEMENT R

    MDR report key: 6045467 · Received October 20, 2016

    Report

    Report Number
    3006946279-2016-00388
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Report Date
    September 22, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    MBB
    PMA / PMN Number
    PK150850
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY TO REVIEW WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. AN INVESTIGATION OF THE COMPLAINT HAS BEEN PERFORMED CONSISTING OF A DOCUMENTARY REVIEW. THE REVIEW OF MANUFACTURING HISTORY SHOWS THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS. ACCORDING TO THE AVAILABLE DATA AND AS THE PRODUCT HAS NOT BEEN RETURNED FOR INSPECTION, THE EXACT ROOT CAUSE OF THE INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION OF THE BONE CEMENT, THE MONOMER LIQUID WOULD NOT DISPENSE INTO THE CYLINDER. THERE WAS NO PATIENT INJURY AND ANOTHER UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694888 OPTIPAC 60 REFOBACIN® BONE CEMENT R BONE CEMENT, ANTIBIOTIC MBB BIOMET FRANCE S.A.R.L. N/A A540B17145

    Patients

    Seq Age Sex Outcome Treatment
    1