BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1070419 · Received June 30, 2008

    Report

    Report Number
    9610622-2008-00098
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 9, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CHIP ON TARGETER WAS FOUND DURING CASE WHEN TARGETING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other