BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 18317873 · Received December 13, 2023

    Report

    Report Number
    9610905-2023-00065
    Event Type
    Injury
    Date Received
    December 13, 2023
    Report Date
    May 16, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118077561
    PMA / PMN Number
    K032442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED USING A STEREO MICROSCOPE REVEALED BREAKAGES. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS. THE COMPLAINT PERCENTAGE WAS CALCULATED, AND IT IS DETERMINED THAT THE COMPLAINT PERCENTAGE FALLS WITHIN THE DESIGN RISK LIMITS ADHERED TO AT KLS SE. DURING THE INVESTIGATION THE PRODUCT LOT NUMBER IDENTIFIED WAS REVIEWED IN THE DEVICE HISTORY RECORDS. THE DHR REVIEW SHOWED NO DISCREPANCIES OR ANOMALIES. THE INVESTIGATION RESULTS CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGES WERE DUE TO STRUCTURAL FAILURE OF THE DEVICE DUE TO MECHANICAL OVERLOAD. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. CORRECTIONS: D3 ESTABLISHMENT NAME - KLS MARTIN SE & CO. KG. G1 CONTACT OFFICE ESTABLISHMENT NAME - KLS-MARTIN L.P. G1 CONTACT OFFICE MANUFACTURING SITE NAME AND ADDRESS - KLS MARTIN SE & CO. KG. KOLBINGER STRASSE 10. MUEHLHEIM/DONAU, DEU 78570, DEU.

    Description of Event or Problem · 0

    IT WAS REPORTED A PLATE BROKE DUE TO PATIENT NON-COMPLIANCE. IT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824029 LEVEL ONE CMF PLATE MQN KLS MARTIN SE & CO. KG 50-730-06-09 33553505 00888118077561

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other