BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCIA FORM PROFILER HANDLE LATERAL RIGHT

    MDR report key: 3931441 · Received April 14, 2014

    Report

    Report Number
    3005673311-2014-00035
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 14, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(4) 2014. ADDITIONAL COMPONENTS INVOLVED DURING PROCEDURE: NG933R X1 (PRODUCTION DATE IS (B)(4) 2013); NG745R X1; NG746R X1; NG755R X1; NG756R X1. TWO NG933R WERE AVAILABLE FOR INVESTIGATION. ADDITIONALLY, 4 PROFILERS WERE SENT. THE SYSTEM WAS TESTED REGARDING THE CONNECTION BETWEEN PROFILERS AND HANDLES. NO DEVIATIONS OR FAILURES WERE FOUND. ALL PROFILERS HOLD ABSOLUTE PROPERLY WITH HANDLES. THE SPRING FORCE OF THE CLAMPING BOLT IS HIGH ENOUGH TO KEEP THE PROFILER SAFELY ATTACHED. THERE ARE NO HINTS FOR MATERIAL OR PRODUCT DEVIATIONS.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). WHEN REMOVING THE PROFILER HANDLE FROM THE OSTEO-PROFILER, THE HANDLE DISCONNECTED FROM THE PROFILER. OPERATION WAS DELAYED OVER 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226784 EXCIA FORM PROFILER HANDLE LATERAL RIGHT PROSTHETIC HIP IMPLANT INSTRUMENT LXH AESCULAP AG & CO. KG NG933R

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other