BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBUNION

    MDR report key: 15501697 · Received September 29, 2022

    Report

    Report Number
    3020584246-2022-00037
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Report Date
    September 26, 2022
    Manufacturer
    CROSSROADS EXTREMITY SYSTEMS
    Product Code
    HRS
    UDI-DI
    00815432027026
    PMA / PMN Number
    K181872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LOT HISTORY RECORD OF THE STERILE IMPLANT AND INDIVIDUAL COMPONENT PART 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: MINIBUNION NON-LOCKING SCREW 3.0MM X 24MM - STERILE KIT, 3100-2716NL, 5000720; MINIBUNION NON-LOCKING SCREW 3.0MM X 24MM COMPONENT, 280246, 103484.

    Description of Event or Problem · 0

    DOCTOR PERFORMED A MINIBUNION SURGERY ON (B)(6) 2019. AT 13 WEEKS POST-OPERATION DURING A FOLLOW-UP VISIT ON (B)(6) 2019, AN X-RAY REVEALED A BROKEN NON-LOCKING SCREW IN A MINIBUNION PLATE. THERE IS NO RESOLUTION TO DATE FOR THIS CASE. DOCTOR REPORTS THAT THE PATIENT IS DOING FINE, AND HE HAS NO PLANS TO REVISE THIS PATIENT OR REMOVE HARDWARE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2926879 MINIBUNION Plate, fixation, bone HRS CROSSROADS EXTREMITY SYSTEMS 3100-2716NL 500720 00815432027026

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other