BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1933404 · Received December 14, 2010

    Report

    Report Number
    9610622-2010-00552
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADD'L INFO IS REC'D IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE NURSE REPORTS IN A FAX THAT THE TARGET DEVICE IS CRACKED AT THE INTERSECTION. THE SURGERY WAS FINISHED WITH AN ALTERNATE TARGET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA LP214133

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other