BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXI+LINE

    MDR report key: 12915285 · Received December 2, 2021

    Report

    Report Number
    3009540749-2021-00040
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 1, 2021
    Manufacturer
    NEXTREMITY SOLUTIONS, INC.
    Product Code
    HRS
    PMA / PMN Number
    K152548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE INFORMATION WAS NOT REPORTED BY THE SURGEON OR THE REPRESENTATIVE WHO REPORTED THE COMPLAINT TO NEXTREMITY SOLUTIONS, INC. THE DEVICE REMAINS IMPLANTED, BUT THE PATIENT IS DUE TO HAVE THE CURRENT PLATE REMOVED, AND REPLACED. THE REPRESENTATIVE WHO REPORTED THE COMPLAINT WILL RETURN THE COMPLAINT DEVICE TO NEXTREMITY ONCE THE REVISION HAS TAKEN PLACE, AND PRODUCT REVIEW CAN BE COMPLETED. THE INFORMATION PROVIDED WAS SPECIFIC TO THE AXI+LINE INSTRUMENT KIT, WHICH DOES NOT CONTAIN THE ACTUAL COMPLAINT DEVICE SO NO DHR INVESTIGATION COULD TAKE PLACE DUE TO LACK OF ACCURATE PART AND LOT INFORMATION FOR THE COMPLAINT DEVICE. THE PLATE IS NOT SOLD INSIDE OF THE KIT, SO TRACEABILITY TO COMPONENTS IN THE KIT COULD NOT BE PERFORMED FOR THIS COMPLAINT. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE COMPLAINT DEVICE IS RECEIVED AND A FULL INVESTIGATION CAN TAKE PLACE.

    Description of Event or Problem · 0

    2ND AXI+LINE CASE BY DR. (B)(6). PROCEDURE WAS THOUGHT TO BE A GREAT CASE. DR. (B)(6) WAS PLEASED WITH HARDWARE AT THE TIME OF SUTURING UP THE PATIENT. THIS IS HIS SECOND AXI+LINE CASE AND LOTS OF MOVEMENT POST OP. PATIENT CLAIMS WB MINIMALLY IN CAM BOOT THE WHOLE TIME. ALIGNMENT OK, BUT HARDWARE WILL LIKELY COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814838 AXI+LINE PLATE HRS NEXTREMITY SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention