BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSCLIP/MOTOCLIP IMPLANT SYSTEM

    MDR report key: 6548540 · Received May 5, 2017

    Report

    Report Number
    3011421599-2017-00002
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    JDR
    UDI-DI
    00815432023127
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON PROVIDED 3 MONTH FOLLOW-UP XRAY THAT INDICATES NON UNION OF THE FIRST DISTAL PHALANGEAL JOINT. TWO 12MM CLIPS WERE USED IN THE INITIAL SURGERY. BASED ON XRAY REVIEW ONE, POSSIBLY BOTH CLIPS ARE BROKEN IN THE BRIDGE/SHOULDER AREA. SURGEON INDICATED POTENTIAL PATIENT NON COMPLIANCE MAY HAVE CONTRIBUTED TO EVENT. REVISION SURGERY IS EXPECTED, BUT NO REVISION SURGERY DATE HAS BEEN PROVIDED. BASED ON INVESTIGATION BY COMPANY, THERE IS NO EVIDENCE TO SUGGEST DEVICE IS OUT OF SPECIFICATION. BASED ON INVESTIGATION AND PATIENT VARIABLES NO CONCLUSION CAN BE MADE AT THIS TIME. DEVICES NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT AGE IS UNKNOWN OR NOT DISCLOSED. SURGEON PROVIDED 3 MONTH XRAY THAT SHOWS A NON UNION OF THE FIRST DISTAL PLANGEAL JOINT. JOINT WAS INITIALLY FIXATED WITH TWO CLIPS. ONE OR BOTH CLIPS APPEAR TO BE BROKEN REVISION SURGERY IS EXPECTED, BUT NO DATE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328774 CROSSCLIP/MOTOCLIP IMPLANT SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE ADN ACCESSORIES JDR CROSSROADS EXTREMITY SYSTEMS, LLC 1412-1212 101491 00815432023127

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention