BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISWISS HIP NAVIGATION SYSTEM

    MDR report key: 20864375 · Received December 6, 2024

    Report

    Report Number
    3017123055-2024-00003
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    October 24, 2022
    Report Date
    November 13, 2023
    Manufacturer
    NAVISWISS AG
    Product Code
    OLO
    PMA / PMN Number
    K193094
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NAVISWISS REPORTED THREE CASES IN ONE REPORT. NAVISWISS ADMITS THAT AT THE TIME OF REPORTING THE EVENT, IT WAS NOT AWARE THAT A SEPARATE REPORT WAS REQUIRED FOR EACH EVENT IN A SERIES OF REPORTABLE MDR EVENTS, AS REQUIRED BY THE FDA GUIDANCE DOCUMENT "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF". THE CURRENT REPORT IS INTENDED TO REMEDY THE OMISSION OF NOT HAVING SUBMITTED A SEPARATE MDR REPORT FOR EACH EVENT. PLEASE REFER TO FOLLOWING NEW REPORTS: MDR 3017123055-2024-00001, MDR 3017123055-2024-00002.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT FOR MDR 3017123055-2023-00001. NAVISWISS REPORTED THREE CASES IN ONE REPORT. NAVISWISS ADMITS THAT AT THE TIME OF REPORTING THE EVENT, IT WAS NOT AWARE THAT A SEPARATE REPORT WAS REQUIRED FOR EACH EVENT IN A SERIES OF REPORTABLE MDR EVENTS, AS REQUIRED BY THE FDA GUIDANCE DOCUMENT "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF". THE CURRENT REPORT IS INTENDED TO REMEDY THE OMISSION OF NOT HAVING SUBMITTED A SEPARATE MDR REPORT FOR EACH EVENT. PLEASE REFER TO FOLLOWING NEW REPORTS: MDR 3017123055-2024-00001, MDR 3017123055-2024-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052116 NAVISWISS HIP NAVIGATION SYSTEM NAVISWISS HIP NAVIGATION SYSTEM OLO NAVISWISS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown