BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    REVOLUTION EXTERNAL PLATING SYSTEM

    MDR report key: 12976390 · Received December 10, 2021

    Report

    Report Number
    3015536247-2020-00007
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    April 7, 2020
    Report Date
    December 8, 2021
    Manufacturer
    NEW STANDARD DEVICE INC.
    Product Code
    KTT
    PMA / PMN Number
    K053472
    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. PATIENT NAME OR OTHER IDENTIFIER. PATIENT WEIGHT. DESCRIPTION OF RELEVANT TESTS, INCLUDING DATES AND LABORATORY DATA. OTHER RELEVANT PATIENT HISTORY INCLUDING PREEXISTING MEDICAL CONDITIONS. MODEL NUMBER. LOT NUMBER. EXPIRATION DATE. UDI. DATE OF DEVICE EXPLANTATION. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    PATIENT: FEMALE (B)(6) 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
    1871979 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