BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICRAFT STALIF C 15 MM ABO PRIMARY T10

    MDR report key: 1793610 · Received August 5, 2010

    Report

    Report Number
    MW5017028
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 5, 2010
    Manufacturer
    SURGICRAFT LTD.
    Product Code
    ODP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICRAFT STALIF C 15 MM ABO PRIMARY T10 SCREW 4 MM DIAMETER, REF: (B)(4), LOT 012055 BROKE DURING ATTEMPTED IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICRAFT STALIF C 15 MM ABO PRIMARY T10 4 MM TI SCREW ODP SURGICRAFT LTD. STALIF C 012055

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR