BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAFORCE

    MDR report key: 15501806 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00032
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    JDR
    UDI-DI
    00815432023363
    PMA / PMN Number
    K142727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY RECORDS OF THE FOLLOWING STERILE IMPLANTS AND INDIVIDUAL COMPONENT PARTS WERE REVIEWED IN THEIR ENTIRETY DURING THE INVESTIGATION. THESE RECORDS INCLUDE QUALITY INSPECTION PROCEDURES, COMPONENT INSPECTION RECORDS, COMPONENT PRINT SPECIFICATIONS, COMPONENT SUPPLIER CERTIFICATES OF CONFORMANCE, SUPPLIER INSPECTION CERTIFICATES, RAW MATERIAL CERTIFICATES OF CONFORMANCE, AND SUPPLIER CERTIFICATES OF COMPLIANCE. NO NON-CONFORMANCES WERE FOUND IN ANY OF THESE RECORDS THAT WERE REVIEWED. DESCRIPTION, PART NUMBER, LOT NUMBER. HIMAX 25MM X 22MM X 22MM - STERILE KIT, 7125-2222KT, 102536. HIMAX 25MM X 22MM X 22MM - COMPONENT, 240012EP, 102444. HIMAX 18MM X 18MM X 18MM - STERILE KIT, 7118-1818KT, 500184. HIMAX 18MM X 18MM X 18MM - COMPONENT, 240008EP, 102887. HIMAX 18MM X 18MM X 18MM - STERILE KIT, 7118-1818KT, 102888. HIMAX 18MM X 18MM X 18MM - COMPONENT, 240008EP, 102887.

    Description of Event or Problem · 0

    DOCTOR REPORTS THAT ON (B)(6) 2018 HE PERFORMED MULTIPLE MIDFOOT AND HINDFOOT FUSIONS ON A PATIENT WITH DIABETES AND DIABETIC NEUROPATHY. AT SOME POINT POST-OPERATION, TWO OF THE STAPLES BROKE ON THE LEGS OF THE IMPLANT. DOCTOR SAYS THE NAVICULAR EXPERIENCES AVASCULAR NECROSIS AND COLLAPSED POST-SURGERY. HE ALSO REPORTS THAT THIS PATIENT WAS NON-COMPLIANT AND WAS WALKING ON THEIR FOOT IN THE 1ST MONTH AFTER THE OPERATION. MOST OF THE AREAS FUSED EXCEPT FOR 1 SMALL PORTION, HE SAYS. ACCORDING TO THE FOLLOW-UP, DOCTOR SAYS THIS PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2942416 DYNAFORCE HIMAX JDR CROSSROADS EXTREMITY SYSTEMS 7118-1818KT 500184 00815432023363

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other