BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 8443484 · Received March 22, 2019

    Report

    Report Number
    3011421599-2018-00005
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    August 29, 2018
    Report Date
    September 24, 2018
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    HRS
    UDI-DI
    00815432025015
    PMA / PMN Number
    K173710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUBMISSION ATTEMPT WAS INITIALLY MADE FOR THIS MDR ON 09/27/2018. AT THE TIME OF THE SUBMISSION, THE ACKNOWLEDGEMENT MESSAGES WERE VIEWED ON FDA WEBTRADER AND IT WAS NOTED THAT THE STATUS WAS LISTED AS DELIVERED UNDER THE ACKNOWLEDGEMENT AND SENT DETAILS SECTIONS. THE ARROW BUTTON TO DOWNLOAD THE HTML TEXT WAS NOT NOTICED AT THE TIME AND THE SUBMISSION ERROR MESSAGE. THE ERROR MESSAGES WERE FOR EXCEEDING THE 50 CHARACTER MAX LIMIT AND AN INVALID DEVICE PROBLEM CODE (3110). THE NITINOL STAPLE IMPLANT WITHIN THE PLATE AND STAPLE CONSTRUCT EXHIBITED MECHANICAL FAILURE IN BOTH LEGS. THE INFORMATION FOR THE NITINOL STAPLE IS LISTED BELOW. BRAND NAME: MOTOCLIP HIMAX IMPLANT SYSTEM. CATALOG NUMBER: 17118-1818KT, LOT NUMER: 103010, EXP DATE: 04/05/2020, UDI: (B)(4), PRODUCT CODE: JDR. ALONG WITH THE NITINOL STAPLE IMPLANT THAT BROKE IN THE PLATE AND STAPLE CONSTRUCT, A SCREW ALSO EXHIBITED MECHANICAL FAILURE. BRAND NAME: MOTOBAND CP LOCKING SCREW 3.0MM X 18MM. CATALOG NUMBER: 1500-3018, LOT NUMER: 500105, EXP DATE: 09/01/2022, UDI: (B)(4), PRODUCT CODE: HWC.

    Description of Event or Problem · 1

    3 MONTH ROUTINE POST OP FOLLOW UP VISIT REVEALED FAILURE OF THE MOTOBAND CP IMPLANT SYSTEM TO PROVIDE ADEQUATE FUSION AT THE FUSION SITE DUE TO BROKEN HARDWARE. DYNAFORCE STAPLE IMPLANT EXPERIENCED MECHANICAL FAILURE IN BOTH LEGS. ADDITIONALLY, ONE OF THE SCREWS EXPERIENCED MECHANICAL FAILURE AS WELL. THE DOCTOR STATED THE PATIENT WAS NON-COMPLIANT. THE JOINT WILL BE REVISED BUT A REVISION DATE HAS NOT BEEN SCHEDULED. X-RAY IMAGE WILL BE INCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238861 MOTOBAND CP IMPLANT SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE HRS CROSSROADS EXTREMITY SYSTEMS LLC 500190 00815432025015

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention