BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOCLIP SUPERELASTIC IMPLANT SYSTEM

    MDR report key: 6018926 · Received October 11, 2016

    Report

    Report Number
    3011421599-2016-00001
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 21, 2016
    Report Date
    October 3, 2016
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED ATTEMPTS FOR ADDITIONAL INFORMATION TO CONFIRM PRODUCT AND COMPLAINT HAVE BEEN UNSUCCESSFUL. DEVICE NOT RETURNED FOR EVALUATION. NO DEVICE RELATED CONCLUSIONS CAN BE MADE AT THIS TIME. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    REPEATED ATTEMPTS FOR ADDITIONAL INFORMATION TO CONFIRM PRODUCT AND COMPLAINT HAVE BEEN UNSUCCESSFUL. DEVICE NOT RETURNED FOR EVALUATION. NO DEVICE RELATED CONCLUSIONS CAN BE MADE AT THIS TIME. AS OF 10/21/2016, SOME ADDITIONAL INFORMATION (E.G. XRAYS) HAS BEEN GATHERED. X-RAYS HAVE BEEN REVIEWED WITH OTHER HEALTH PROFESSIONALS. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD A NON-UNION THAT INVOLVED A MOTOCLIP IMPLANT. IMPLANT ALLEGEDLY BROKE. NO XRAYS PROVIDED TO DATE. SPECIFIC IMPLANT INFORMATION NOT PROVIDED. REPORTEDLY, THE CLIP WAS REPLACED WITH A PLATE.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD A NON-UNION THAT INVOLVED A MOTOCLIP IMPLANT. IMPLANT ALLEGEDLY BROKE. NO XRAYS PROVIDED TO DATE. SPECIFIC IMPLANT INFORMATION NOT PROVIDED. REPORTEDLY, THE CLIP WAS REPLACED WITH A PLATE. UPDATED 10/21/2016 - X-RAYS PROVIDED. 18MM CLIP APPEARS TO HAVE BROKEN. CLIP WAS USED TO SPAN FROM THE 2ND METATARSAL TO THE FIRST CUNEIFORM. POST-OPERATIVE CARE NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669735 MOTOCLIP SUPERELASTIC IMPLANT SYSTEM STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS NOT KNOWN AT THIS TIME NOT KNOWN AT THIS TIME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention