BEUDAMED
    FDA Adverse Event Other Summary report: N

    IFORMA

    MDR report key: 2304645 · Received March 13, 2008

    Report

    Report Number
    3004153240-2008-00003
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 13, 2008
    Manufacturer
    CONFORMIS, INC.
    Product Code
    HSH
    PMA / PMN Number
    K033242
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. (B)(6) STANDARD FOR THE MATERIAL FOR WHICH THE IMPLANT WAS MADE SPECIFIED NICKEL CONTENT WHICH WAS BELIEVED TO BE THE CAUSE OF THE PATIENT'S POSSIBLE ALLERGIC REACTION.

    Description of Event or Problem · 1

    PATIENT REPORTS A HISTORY OF "MANY ALLERGIES" AND A POSSIBLE NICKEL ALLERGY. PRIOR TO IMPLANTING THE DEVICE, THE SURGEON REQUESTED AN EVALUATION BY AN ALLERGIST. TO ASSIST IN THE EVALUATION, THE ALLERGIST REQUESTED A POLISHED DISK OF THE IMPLANT MATERIAL FOR (B)(6) TESTING, WHICH WAS CARRIED OUT AND WAS APPARENTLY NEGATIVE. THE DEVICE WAS IMPLANTED. APPROX. 7.5 MONTHS LATER, THE PATIENT REPORTED WHAT APPEARED TO BE SYMPTOMS OF AN ALLERGIC RESPONSE AND THE DECISION WAS MADE TO REMOVE THE DEVICE. REMOVAL IS PLANNED FOR NEXT WEEK AT AN (B)(6) AND HOSPITALIZATION WILL NOT BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IFORMA HSH CONFORMIS, INC. 160.20 0000445

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention NONE REPORTED TO MANUFACTURER