BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTION

    MDR report key: 19996202 · Received August 15, 2024

    Report

    Report Number
    9610905-2024-00057
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    June 3, 2024
    Report Date
    January 17, 2025
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118127891
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS SUCCESSFULLY COMPLETED. THE RESULTS OF THE INVESTIGATION HAVE IDENTIFIED A KNOWN INHERENT RISK OF THE DEVICE. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED A DISTRACTOR BROKE DUE TO UNKNOWN REASONS. IT WAS REMOVED AND REPLACED PRIOR TO THE CONSOLIDATION PHASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619962 DISTRACTION DISTRACTOR MQN KLS MARTIN SE & CO. KG 51-406-33-09 33436999 00888118127891

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other