BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION EXTERNAL PLATING SYSTEM

    MDR report key: 13564217 · Received February 18, 2022

    Report

    Report Number
    3015536247-2020-00072
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    April 7, 2020
    Report Date
    December 8, 2021
    Manufacturer
    NEW STANDARD DEVICE INC.
    Product Code
    KTT
    PMA / PMN Number
    K053472
    Removal / Correction Number
    CR-20-002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION IS OMITTED FROM THIS REPORT AS IT IS NOT AVAILABLE. TWO FOLLOW-UP ATTEMPTS WERE MADE TO SECURE THIS INFORMATION FROM THE INITIAL REPORTER BUT NONE IS AVAILABLE AT THE TIME THIS REPORT WAS SUBMITTED.

    Description of Event or Problem · 0

    PATIENT: FEMALE, 18 Y/O, HEALTHY WITH GOOD QUALITY BONE. OCCURRENCE: DR. (B)(6) WAS INSERTING THE HALF-PIN WITH A POWER DRILL (NOT BY HAND). PIN PASSED THRU 1ST CORTEX NORMALLY, INDICATED EXTRA FORCE HAD TO BE APPLIED TO DRILL TO CONTINUE THE INSERTION, HALF-PIN STARTED INSERTING INTO THE SECOND CORTEX AND HE HEARD A POP, THE TIP BROKE. HE LEFT THE PIN IN PLACE AND THE METAL WILL BE LEFT IN THE PATIENT WITH THE HALF-PIN IS REMOVED IN APPROX 3-6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437109 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 18 YR Female