BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE THORACIC

    MDR report key: 19772055 · Received July 18, 2024

    Report

    Report Number
    9610905-2024-00043
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 18, 2024
    Report Date
    June 18, 2024
    Manufacturer
    KLS MARTIN SE & CO. KG
    Product Code
    HRS
    UDI-DI
    00888118121264
    PMA / PMN Number
    K153482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PATIENT 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.

    Description of Event or Problem · 0

    A THORACIC RIB PLATE SECURING AN UNHEALED RIB WITH A NON-UNION FRACTURED THREE YEARS AFTER IMPLANT. IT WAS REMOVED AND REPLACED IN ORDER TO RE-FIXATE THE RIB FOR PROPER CONSOLIDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501224 LEVEL ONE THORACIC PLATE HRS KLS MARTIN SE & CO. KG 24-015-32-71 UNKNOWN 00888118121264

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other