BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 18539766 · Received January 18, 2024

    Report

    Report Number
    9610905-2023-00071
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 14, 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. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE DUE TO NO LOT NUMBER BEING IDENTIFIED. THE INVESTIGATION RESULTS CONCLUDE THAT THE ROOT CAUSE FOR THIS FAILURE COULD NOT BE DETERMINED. 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 THAT NON-LOCKING SCREWS WHICH REMAINED SECURED TO A FIXATION PLATE BECAME LOOSENED FROM A PATIENT'S COMPROMISED BONE EIGHT WEEKS AFTER IMPLANT. THEY WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406314 LEVEL ONE CMF SCREW JEY KLS MARTIN SE & CO. KG 25-872-05-91 UNKNOWN 00888118046697

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other