BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 19670597 · Received July 3, 2024

    Report

    Report Number
    9610905-2024-00041
    Event Type
    Injury
    Date Received
    July 3, 2024
    Report Date
    June 4, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    JEY
    PMA / PMN Number
    K943347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MATERIAL NUMBER NOR LOT NUMBER WAS IDENTIFIED THEREFORE COMPLAINT RATE, REVIEW OF DEVICE HISTORY RECORDS AND RISK FILE WAS NOT POSSIBLE. THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED SINCE NEITHER MATERIAL NUMBER NOR LOT NUMBER WERE PROVIDED, AND THE DEVICE WAS NOT RETURNED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.  POSSIBLE MATERIAL NUMBER IDENTIFIED: 25-872-05-91.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNKNOWN FIXATION SCREW IMPLANTED IN A MANDIBLE HAD BECOME LOOSENED FROM COMPROMISED BONE 8 MONTHS AFTER IMPLANTATION. IT WAS REMOVED, DISCARDED, AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959492 LEVEL ONE CMF SCREW JEY KLS MARTIN SE & CO. KG UNKNOWN SEE H11 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other