BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOCLIP

    MDR report key: 15501680 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00027
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    May 24, 2019
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00815432023325
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE PATIENT SUBMITTED MDR TO THE FDA, THE COMPLAINT SUGGESTS THAT THE MOTOCLIP IMPLANT WAS DEFECTIVE AND BROKEN WHEN IT WAS IMPLANTED. HOWEVER, THERE IS NO OBJECTIVE EVIDENCE TO CONFIRM THIS COMPLAINT. THE MDR SAYS THE SURGERY WAS FOR A 2ND TMT AND 3RD TMT FUSION. THE PATIENT FURTHER ALLEGES THAT THE CLIP HAS CAUSED PAIN, LIMPING, BACK MISALIGNMENT, AND RIGHT KNEE PAIN. THE MDR STATES THE DEVICE IS AVAILABLE FOR EVALUATION, BUT NO INFORMATION IS PROVIDED. THE FOLLOWING LHR RECORDS WERE INVESTIGATED AND NO INFORMATION WAS FOUND TO SUGGEST THE DEVICE WAS NOT WITHIN SPECIFICATIONS. DESCRIPTION: PART NUMBER, LOT NUMBER, MOTOCLIP SUPER ELASTIC FUSION SYSTEM 18MM X 14MM X 14MM 1442-1814 101909, MOTOCLIP SUPER ELASTIC FUSION SYSTEM 18MM X 14MM X 14MM 1442-1814 101848.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS RECEIVED BY MAIL THROUGH AN FDA MEDICAL DEVICE REPORT (MDR) THAT WAS WRITTEN BY A PATIENT. ALLEGEDLY, THE PATIENT STATES THAT THEY HAVE A DEFECTIVE AND BROKEN CLIP THAT HAS CAUSED LIMPING, BACK MISALIGNMENT AND KNEE PAIN. THE PATIENT IS CONVINCED THE CLIP WAS BROKEN AND DEFECTIVE AT THE TIME OF IMPLANTATION, ACCORDING TO THE REPORT (MW5086568).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926603 MOTOCLIP STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS 1442-1814 101909 00815432023325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other