BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 20162535 · Received September 6, 2024

    Report

    Report Number
    9610905-2024-00053
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HRS
    PMA / PMN Number
    K971297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS PERFORMED ON THE BASIS OF COMPLAINT STATISTICS AS NO DEVICE WAS RETURNED FOR EVALUATION. 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 WAS NOT IDENTIFIED; THEREFORE, THE DEVICE HISTORY RECORDS WERE NOT REVIEWED. BASED ON THE INFORMATION PROVIDED THE RESULTS CONCLUDE THAT THE MOST LIKELY ROOT CAUSE IS USE RELATED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED. D4 - MATERIAL. POSSIBLE MATERIAL IDENTIFIED: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CMF SCREWS DID NOT FIXATE BSSO PLATE WHICH SURGEONS HAD MODIFIED INTRA-OPERATIVELY BY DRILLING NEW SCREW HOLES INTO WHICH THE SCREWS WERE FITTED. THE MODIFIED HARDWARE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225517 LEVEL ONE CMF SCREW HRS KLS MARTIN SE & CO. KG SEE H11 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other