BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL RESECTION GUIDE STAND

    MDR report key: 3852207 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02143
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 20, 2014
    Report Date
    October 6, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN FEMORAL GUIDE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY SURGERY OF RIGHT KNEE PART OF THE FEMORAL GUIDE WELD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329016 DISTAL RESECTION GUIDE STAND ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH 10067401

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other