BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 18530550 · Received January 17, 2024

    Report

    Report Number
    9610905-2023-00075
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 19, 2023
    Report Date
    May 15, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    JEY
    UDI-DI
    00888118046697
    PMA / PMN Number
    K943347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED IN THE LAB AND 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 IS PATIENT RELATED AS NO DEVICE ISSUE WAS FOUND. 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 (B)(6) G1 CONTACT OFFICE ESTABLISHMENT NAME (B)(6) 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

    CMF SCREWS IMPLANTED 14 MONTHS EARLIER BECAME PARTIALLY LOOSENED FROM COMPROMISED BONE DUE TO SUBSEQUENT PATIENT BONE EDEMA UNRELATED TO IMPLANTED HARDWARE. THEY WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627123 LEVEL ONE CMF SCREW JEY KLS MARTIN SE & CO. KG 25-872-05-91 33502371 00888118046697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other