BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSTIE

    MDR report key: 15501692 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00048
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    November 10, 2020
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027736
    PMA / PMN Number
    K190722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY RECORDS OF THE STERILE AND INDIVIDUAL COMPONENT PARTS WERE REVIEWED IN THEIR ENTIRETY DURING THE INVESTIGATION. THESE RECORDS INCLUDED QUALITY INSPECTION RECORDS, COMPONENT INSPECTION RECORDS, COMPONENT PRINT SPECIFICATION, COMPONENT SUPPLIER CERTIFICATES OF CONFORMANCE, SUPPLIER INSPECTION CERTIFICATES, RAW MATERIAL CERTIFICATES OF CONFORMANCE, AND SUPPLIER CERTIFICATES OF CONFORMANCE. NO NON-CONFORMANCES WERE FOUND IN ANY RECORDS THAT WERE REVIEWED THAT WOULD HAVE CONTRIBUTED TO THE DEVICE FAILURE. 7318-1818 500917. KEEL-LOCK 18MM X 18 MM X 18MM STERILE. 240509-EP. 103968. KEEL-LOCK 18MM X 18 MM X 18MM.

    Description of Event or Problem · 0

    AT ROUTINE FOLLOW-UP, A FRACTURED KEEL-LOCK STAPLE LEG WAS IDENTIFIED IN THE FOLLOW-UP X-RAY. TN FUSION HAS OCCURRED, AND THE PATIENT IS ASYMPTOMATIC. THE SURGEON DOES NOT PLAN TO REVISE THE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2926874 CROSSTIE KEEL LOCK HRS CROSSROADS EXTREMITY SYSTEMS 7318-1818 500917 00815432027736

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other