BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOCLIP SUPER ELASTIC FUSION SYSTEM

    MDR report key: 8604618 · Received May 10, 2019

    Report

    Report Number
    MW5086568
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    May 10, 2017
    Report Date
    May 8, 2019
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    JDR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SURGERY TO MY LEFT FOOT TO IMPLANT, 2 STAPLES IN AN ATTEMPT TO FUSE THE 2ND METATARSAL TO THE 2ND CUNEIFORM AND 3RD METATARSAL TO THE 3RD CUNEIFORM. AFTER SEVERAL MONTHS OF CONTINUOUS PAIN I WENT TO ANOTHER DR (DR (B)(6) MD, ORTHOPEDIC SURGEON) FOR A SECOND OPINION. HIS X-RAYS SHOWED THE STAPLE ON THE 2ND METATARSAL / CUNEIFORM WAS BROKEN. CONTINUED PAIN HAS CAUSED SIGNIFICANT LIMPING, WHICH IN TURN CAUSED MY BACK TO BECOME MISALIGNED, WHICH IN TURN CAUSED MY RIGHT KNEE TO BECOME PAINFUL AS WELL. I AM CONVINCED THAT THE PRODUCT WAS DEFECTIVE AND BROKEN WHEN IT WAS IMPLANTED. IMPLANT NAME: MOTO CLIP SUPER ELASTIC FUSION SYSTEM, MODEL NUMBER: 1442-1814, LOT NUMBER: 1011848 AND 101909, EXP DATE: 05/14/2018 AND 01/12/2019, SURGEON: DR (B)(6), DPM ASSISTANT SURGEON: (B)(6), DPM SURGERY DATE: (B)(6) 2017, PERFORMED AT (B)(6). DISCOVERY OF BROKEN STAPLE: (B)(6) 2018 (DR (B)(6)). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391820 MOTOCLIP SUPER ELASTIC FUSION SYSTEM STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS LLC 1442-1814 1011848
    391821 MOTOCLIP SUPER ELASTIC FUSION SYSTEM STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS LLC 1442-1814 101909

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability