BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDLOC 2/0 PANACRYL (PLA/PDS) STRAIGHT

    MDR report key: 1791875 · Received August 4, 2010

    Report

    Report Number
    1221934-2010-00265
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 27, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE COMPLAINT DEVICE IS REPORTEDLY IN ROUTE TO MITEK FOR EVALUATION. IF AND WHEN THE DEVICE IS RECEIVED, THE RESULTS WILL BE REFLECTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    FOR THIS PROCEDURE, THE SURGEON HAD TO USE THREE RAPIDLOC¿S TO COMPLETE CASE SUCCESSFULLY. ONE OF THESE DEVICES, THE TOPHAT BROKE AWAY FROM THE SUTURE AND FELL INTO THE PATIENT¿S JOINT SPACE. THE TIME OF PROCEDURE WAS EXTENDED 30 MINS. NO FURTHER ACTION IS REQUIRED AT THIS POINT IN TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPIDLOC 2/0 PANACRYL (PLA/PDS) STRAIGHT RAPIDLOC STRAIGHT MBI DEPUY MITEK 228310 3409539

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK