BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ANGLE PLATE

    MDR report key: 75264 · Received March 4, 1997

    Report

    Report Number
    8010177-1997-00003
    Event Type
    Malfunction
    Date Received
    March 4, 1997
    Date of Event
    November 25, 1996
    Report Date
    February 28, 1997
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HRS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: THE DEVICE IS NOT MANUFACTURED IN THE U.S. EVAL WAS PERFORMED BY MFR IN FREIBURG, GERMANY. A LOCKING-SCREW MANDIBULAR RECONSTRUCTION PLATE BROKE POST-OPERATIVELY IN THE PT. THE FAILURE WAS NOTICED BY THE PT. THE PLATE FRAGMENTS WERE RETURNED FOR EXAMINATION. IN ORDER TO ASSESS THE FAILURE REASON A FRACTOGRAPHIC EXAMINATION WAS CARRIED OUT BY AN EXTERNAL LABORATORY. THE FRACTOGRAPHIC ANALYSIS DISPLAYS A FRACTURE SURFACE TYPICAL FOR FATIGURE FRACTURE. THE PLATE FAILURE WAS CAUSED BY CYCLIC LOAD CONDITIONS EXCEEDING THE FATIGUE STRENGTH OF THE MATERIAL AT A PLATE PORTION SUBJECT TO TENSILE LOAD DURING MASTICATION. NO MATERIAL FLAW OR SURFACE DAMAGE COULD BE DETECTED AT THE CRACK ORIGIN AND IT'S VICINITY. A REDESIGN PROJECT HAS BEEN INITIATED TO IMPROVE THE RELIABILITY AND PERFORMANCE OF THIS DEVICE. NO FURTHER CORRECTIVE ACTION IS CONSIDERED TO BE NECESSARY

    Description of Event or Problem · 1

    THE REPORTER STATES THE PLATE BROKE AND WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW ANGLE PLATE Implant FRACTURE FIXATION APPLIANCE HRS STRYKER INSTRUMENTS NA 3574-1037

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other