BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSCLIP

    MDR report key: 15501689 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00024
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    July 10, 2018
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LHR'S WERE REVIEWED AND NO EVIDENCE WAS FOUND TO SUGGEST THE DEVICE DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. 7118-1818KT, 500038, 240008EP, 102435, 240008, 102421(173460-01). BASED ON INVESTIGATION, DO DEFECTS WERE IDENTIFIED FOR THE CROSSROAD IMPLANT THAT WAS USED. IT IS ASSUMED THAT THE IMPLANT BROKE DUE TO REPETITIVE STRESSES EXERTED ON THE IMPLANT PRIOR TO BONE FUSION.

    Description of Event or Problem · 0

    DURING A ROUTINE 2 MONTH FOLLOW UP VISIT, DOCTOR DISCOVERED THAT THE 18MM DYNAFORCE IMPLANT HAD FRACTURED IN THE LEG OF THE IMPLANT. THE SITE APPEARED TO BE FUSED PROPERLY AND NO REVISION SURGERY WAS PLANNED. ACCORDING TO A CONVERSATION REP HAD WITH THE DOCTOR, DOCTOR BELIEVES THAT PATIENT WAS NON-COMPLAINT. ADDITIONALLY, DOCTOR IS CONTENT WITH THE PERFORMANCE OF IMPLANTS DUE TO THE FUSION EXHIBITED AT THE SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2926871 CROSSCLIP STAPLE, FIXATION, BONE JDR CROSSROADS EXTREMITY SYSTEMS 7118-1818KT 500038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other