BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTRACTION

    MDR report key: 7552578 · Received May 30, 2018

    Report

    Report Number
    9610905-2018-00073
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 7, 2018
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118075635
    PMA / PMN Number
    K010139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCE EXEMPTION NUMBER E2017029. CORRECTING THE MFR REPORT NUMBER DUE TO A TYPO. THIS WAS ORIGINALLY SUBMITTED AS 9610905-2018-02018 ON 05/29/2018. THIS WAS ORIGINALLY CORRECTED WITH 9610905-2018-00073-1 ON 05/30/2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS BECAME LOOSE. THE SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398040 DISTRACTION DISTRACTION MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 50-348-05-09 UNKNOWN 00888118075635

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Other (B)(4), DISTRACTION, INTERNAL