BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSCLIP/MOTOCLIP IMPLANT SYSTEM

    MDR report key: 6548514 · Received May 5, 2017

    Report

    Report Number
    3011421599-2017-00003
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    JDR
    UDI-DI
    0085031006120
    PMA / PMN Number
    K142727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON PROVIDED 3 MO FOLLOW-UP XRAYS. XRAYS SHOW FUSED JOINT. CLIP LEG APPEARS TO BE FRACTURED. PER SURGEON, JOINT IS PROPERLY FUSED AND NO REVISION SURGERY IS PLANNED OR ANTICIPATED. EVENT HAS NO ADVERSE IMPACT ON PATIENT AT THIS TIME. DEVICE RETURN NOT EXPECTED.

    Description of Event or Problem · 1

    PATIENT AGE AND WEIGHT UNKNOWN OR NOT DISCLOSED. REPORT OF BROKEN CLIP IN FUSED JOINT - NO REVISION SURGERY PLANNED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329513 CROSSCLIP/MOTOCLIP IMPLANT SYSTEM SINGLE/MULTIPLE COMPONETN METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES JDR CROSSROADS EXTREMITY SYSTEMS, LLC 1442-2522 101146 0085031006120

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR