BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE

    MDR report key: 19772057 · Received July 18, 2024

    Report

    Report Number
    9610905-2024-00046
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 24, 2024
    Report Date
    January 15, 2025
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HTW
    UDI-DI
    00888118040985
    PMA / PMN Number
    CLS 1 EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS SUCCESSFULLY COMPLETED. THE RESULTS OF THE INVESTIGATION HAVE IDENTIFIED NO MANUFACTURING ISSUES, NO DESIGN ISSUES AND/OR CORRECTIVE ACTIONS NECESSARY AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. THE REPORTED RPMS EXCEEDED THE MAXIMUM RECOMMENDED SPEED FOUND IN THE IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING INITIAL SURGERY A TWIST DRILL BROKE DURING USE. A PORTION OF IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501226 LEVEL ONE TWIST DRILL HTW KLS MARTIN SE & CO. KG 25-452-07-91 33574307 00888118040985

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Other