BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION EXTERNAL PLATING SYSTEM

    MDR report key: 13082790 · Received December 23, 2021

    Report

    Report Number
    3015536247-2020-00004
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    February 13, 2020
    Report Date
    December 23, 2021
    Manufacturer
    NEW STANDARD DEVICE INC.
    Product Code
    KTT
    PMA / PMN Number
    K053472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION IS OMITTED FROM THIS REPORT AS IT WAS NOT AVAILABLE AT THE TIME THE REPORT WAS SUBMITTED: PATIENT IDENTIFIER, PATIENT AGE, DOB, PATIENT GENDER, PATIENT WEIGHT, ETHNICITY, RACE, RELEVANT TESTS/LABORATORY DATA, CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES, DEVICE LOT #, EXPLANT DATE, DEVICE MFR DATE, AND REMOVAL ACTION #.

    Description of Event or Problem · 0

    (B)(6)STATED THAT: "DR. (B)(6) REMOVED A REVOLUTION FRAME TODAY AND IT HAD (4) BROKEN TRUSS WIRES. SHE HAS HAD BROKEN TRUSS WIRES BEFORE, (B)(6) INDICATED THAT DR. (B)(6) OR THE PATIENT DID NOT KNOW THAT THE WIRES WERE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969894 REVOLUTION EXTERNAL PLATING SYSTEM SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES KTT NEW STANDARD DEVICE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown