BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALLU-C PLATE SIZE UNKNOWN

    MDR report key: 1240866 · Received November 6, 2008

    Report

    Report Number
    9615741-2008-00027
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 5, 2008
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED IN A TELEPHONE CALL TO AN INTEGRA SALES REPRESENTATIVE THAT A HALLU-FIX PLATE WAS IMPLANTED INTO HER FOOT IN (B) (6) 2006, FOLLOWING A CRUSH INJURY. THE PATIENT STATED THAT HER TOE IS NOW STICKING UP AN INCH OR TWO ABOVE THE GROUND. SHE STATED THAT DURING A PROCEDURE TO REMOVE THE DEVICE, THE SURGEON WAS UNABLE TO EXTRACT THE SCREWS BECAUSE THEY WERE "SHEARED OFF". INTEGRA HAS CALLED FOR FURTHER INFO. NO RESPONSE HAS BEEN RECEIVED TO DATE. INTEGRA HAS REQUESTED IN WRITING FURTHER INFO FROM THE SURGEON TO DETERMINE THE EXACT IDENTITY OF THE PRODUCT AND ADDITIONAL CLINICAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALLU-C PLATE SIZE UNKNOWN LOWER EXTREMITY ORTHOPEDIC FIXATION HRS NEWDEAL S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention