BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAFORCE

    MDR report key: 7151709 · Received December 28, 2017

    Report

    Report Number
    3011421599-2017-00009
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 27, 2017
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS LLC
    Product Code
    JDR
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE BASED ON THE INFORMATION AVAILABLE. THE DEVICE LOT HISTORY RECORDS AND MANUFACTURING RECORDS WERE REVIEWED AND NO EVIDENCE WAS FOUND TO SUGGEST THE DEVICE DID NOT MEET SPECIFICATIONS PRIOR TO DISTRIBUTION. X-RAYS HAVE NOT BEEN OBTAINED TO CONFIRM THE FAILURE OF THE IMPLANT AND THE REPORTED NON-UNION. THE CATALOG PART NUMBER FOR THE IMPLANT THAT IS REPORTED TO HAVE EXPERIENCED FAILURE IS 7120-2020KT HOWEVER THE LOT NUMBER IS UNKNOWN BECAUSE TWO IMPLANTS WITH THE SAME PART NUMBER WERE USED IN THIS CASE. X-RAYS AND PICTURES OF THE BROKEN IMPLANT HAVE NOT BEEN RECEIVED. PER THE DOCTOR, THE IMPLANT FRACTURED IN THE LEG 3-4MM FROM THE TOP OF THE BRIDGE. ACCORDING TO THE DOCTOR, THERE WAS A HOST OF FACTORS WHICH HE BELIEVES MAY HAVE CONTRIBUTED TO THE MECHANICAL FAILURE OF THE IMPLANT AND THE RESULTING NON-UNION. THESE FACTORS INCLUDE: PATIENT COMPLIANCE WITH WEIGHT BEARING POST OP, BONE QUALITY, GENTETIC ABILITY TO MOBILIZE OSTEOCYTES TO THE FUSION/FRACTURE SITE, AND THE PATIENT IS A SMOKER.

    Description of Event or Problem · 1

    ORIGINAL SURGERY DATE - (B)(6) 2017. FAILURE DETECTION OCCURRED 5 MONTHS POST OP (END OF (B)(6)). POST OPERATIVE FOLLOW UP VISIT DISCOVERED ONE NITONOL STAPLE FRACTURE AND NON-UNION OF FUSION SITE. PER SURGEON, THE PATIENT HAD A HOST OF FACTORS WHICH MAY HAVE CONTRIBUTED TO THE MECHANICAL FAILURE OF THE IMPLANT AND THE NON-UNION OF THE FUSION SITE. THESE FACTORS INCLUDE: PATIENT NON-COMPLIANCE IN REGARDS TO WEIGHT BEARING, POOR BONE QUALITY, GENETIC ABILITY TO MOBILIZE OSTEOCYTES TO THE FUSION/FRACTURE SITE, AND THE PATIENT WAS A SMOKER. THE REVSION SURGERY INVOLVED REMOVING THE BROKEN DEVICE AND IMPLANTING A NEW STAPLE IMPLANT USED IN COMBINATION WITH A PLATE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931991 DYNAFORCE BONE STAPLE, SINGLE/MULTIPLE COMPONENT BONE FIXATION APPLIANCE JDR CROSSROADS EXTREMITY SYSTEMS LLC 240011EP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention