BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2132216 · Received June 14, 2011

    Report

    Report Number
    8030965-2011-00282
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 30, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS UNABLE TO DETERMINE MFG SITE OR MFG DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER.

    Description of Event or Problem · 1

    PT WITH HALLUX SURGERY OF THE RIGHT FOOT WAS TREATED WITH 5 STAINLESS STEEL SCREWS. A FEW WEEKS POSTOP, PT PRESENTED WITH ALLERGIC REACTION. THREE MONTHS POSTOP THE SCREWS WERE REMOVED. THIS IS THE 2ND OF 5 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SCREW HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS