BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 8103556 · Received November 26, 2018

    Report

    Report Number
    9610905-2018-00312
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 30, 2018
    Report Date
    October 30, 2018
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    NEI
    UDI-DI
    00888118073570
    PMA / PMN Number
    K990667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REFERENCE EXEMPTION NUMBER E2017029.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW BROKE DURING IMPLANTATION. A PORTION REMAINED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    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 KLM. DURING THE INVESTIGATION THE PRODUCT LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, THE DEVICE HISTORY RECORDS WERE NOT REVIEWED. THE FAILURE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE DEVICE NOT BEING RETURNED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940115 LEVEL ONE CMF SCREW NEI KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 50-174-03-91 00888118073570

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other