BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, INSERTER

    MDR report key: 2182147 · Received June 23, 2011

    Report

    Report Number
    9610622-2011-00276
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ITEM BROKE WHILE IN USE. ANOTHER ITEM WAS USED AND CASE COMPLETED AS ORIGINALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, INSERTER INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K566667

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other