BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMED ULNAR OSTEOTOMY SYSTEM

    MDR report key: 2524915 · Received March 30, 2012

    Report

    Report Number
    2031009-2012-00010
    Date Received
    March 30, 2012
    Date of Event
    December 14, 2010
    Report Date
    March 30, 2012
    Manufacturer
    TRIMED, INC.
    Product Code
    HRS
    PMA / PMN Number
    K043263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT ALLERGIC REACTION TO DEVICE MATERIAL.

    Description of Event or Problem · 1

    PT HAD AN ALLERGIC REACTION TO THE MEDICAL DEVICES (PLATES AND SCREWS) THAT WERE IMPLANTED. DEVICES WERE ALL MADE FROM IMPLANTABLE GRADE STAINLESS STEEL MATERIAL. PART LIST IMPLANTED. PLATE: UOCP (L/N: 24970). SCREWS: HEX3.2-12 (L/N: 51241). LAG3.2-16 (L/N: 41481).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIMED ULNAR OSTEOTOMY SYSTEM ULNAR OSTEOTOMY SYSTEM HRS TRIMED, INC. UOCP, HEX3.2, ETC. VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention