BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE

    MDR report key: 20034211 · Received August 22, 2024

    Report

    Report Number
    9610905-2024-00056
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    January 13, 2025
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HTW
    UDI-DI
    00888118040954
    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. LOTS IDENTIFIED: 33490322 - MFG DATE 07/22/2022, 33520373 - MFG DATE 12/19/2022, 33610901 - MFG DATE 05/21/2024.

    Additional Manufacturer Narrative · 0

    D4 - POSSIBLE LOT NUMBERS IDENTIFIED: 33490322. 33520373. 33610901.

    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
    17799 LEVEL ONE TWIST DRILL HTW KLS MARTIN SE & CO. KG 25-452-00-91 SEE H11 00888118040954

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Other