BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTOBAND CP IMPLANT SYSTEM

    MDR report key: 8443473 · Received March 22, 2019

    Report

    Report Number
    3011421599-2018-00004
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    June 22, 2018
    Report Date
    July 19, 2018
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432025039
    PMA / PMN Number
    K160300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAUSE OF MALFUNCTION IS UNDETERMINED. DEVICE HAS NOT BEEN RECEIVED. SURGEON HAS NOT BEEN ABLE TO BE REACHED FOR COMMENT. ON 03/21/2019- A SUBMISSION ATTEMPT WAS INITIALLY MADE FOR THIS MDR ON (B)(6) 2018. THE ACKNOWLEDGEMENT WAS VIEWED ON FDA WEBTRADER. THE STATUS WAS NOTED AS DELIVERED UNDER THE ACKNOWLEDGEMENT AND SENT DETAILS SECTION. THE ARROW BUTTON FOR THE HTML DOWNLOAD WAS NOT NOTICED AND THE SUBMISSION ERROR WAS NOT SEEN. THE ERROR MESSAGE WAS FOR EXCEEDING THE MAX CHARACTER COUNT. THE INFORMATION THAT WAS PREVIOUSLY LISTED HAS BEEN POSTED BELOW. THE PLATE LISTED PREVIOUSLY WAS USED IN CONJUNCTION WITH THE IMPLANTS LISTED BELOW AS A TOTAL CONSTRUCT FOR BONE FRAGMENT OSTEOTOMY FIXATION AND JOINT ARTHRODESIS. NITINOL STAPLE IMPLANT - DYNAFORCE HIMAX IMPLANT, PN-7118-1414KT, LOT-102892, UDI-(B)(4). PLATE LOCKING SCREW 3.0MM X 8MM, PN-1500-3008, LOT-101299, UDI-(B)(4). PLATE LOCKING SCREW 3.0MM X 12MM, PN-1500-3012, LOT-101423, UDI-(B)(4). PLATE LOCKING SCREW 3.0MM X 14MM, PN-1500-3014, LOT-102355, UDI-(B)(4). PLATE LOCKING SCREW 3.0MM X 18MM, PM-1500-3018, LOT-101426, UDI-(B)(4). PLATE NON-LOCKING SCREW 3.0MM X 18, PN-1500-3518, LOT-102345, UDI-(B)(4). PLATE NON-LOCKING SCREW 3.0MM X 18, PN-1500-3518, LOT-500084, UDI-(B)(4).

    Description of Event or Problem · 1

    A DYNAFORCE CLIP AND MPJ PLATE CONSTRUCT WAS IMPLANTED IN THE PATIENT ON (B)(6) 2018. DURING A 2 MONTH FOLLOW UP VISIT IT WAS DISCOVERED THAT THE PLATE HAD ELEVATED FROM THE BONE AND A NON-UNION WAS PRESENT AT THE FUSION SITE. ON (B)(6) 2018, THE DYNAFORCE CONSTRUCT WAS REMOVED AND ANOTHER PLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237948 MOTOBAND CP IMPLANT SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCE HRS CROSSROADS EXTREMITY SYSTEMS 500192 00815432025039

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention