BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALLU-C PLATE SIZE 2 RIGHT

    MDR report key: 1202847 · Received October 16, 2008

    Report

    Report Number
    9615741-2008-00025
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 16, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR RETURN FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE RPTR STATED THAT THE IMPLANTED DEVICE BROKE. IT WAS REMOVED ABOUT ONE YEAR AFTER IMPLANTATION. THE PHYSICIAN REPORTED THAT THE PT WAS NON-COMPLAINT WITH POST OPERATIVE INSTRUCTIONS AND NEVER ATTENDED POST OPERATIVE VISITS. THE PHYSICIAN STATED THAT THE PT HAD WALKED ON THE PLATE RIGHT AWAY AND CONSIDERED THAT TO BE THE CAUSE OF THE BREAKAGE. THE BROKEN PLATE WAS DISCARDED AT THE USER FACILITY. INTEGRA HAS CONTACTED THE PHYSICIAN IN WRITING TO REQUEST FURTHER CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU-C PLATE SIZE 2 RIGHT FOREFOOT ORTHOPAEDIC FIXATION HRS NEWDEAL S.A. E5E2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention