BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWS ASNIS III 4.0X30MM TL10MM

    MDR report key: 1892823 · Received November 3, 2010

    Report

    Report Number
    8031020-2010-00148
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    PMA / PMN Number
    K000080
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, WHEN DOCTOR TRIED TO IMPLANT SCREW, IT GOT STUCK ON THE K-WIRE AND WE COULD NOT GET IT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREWS ASNIS III 4.0X30MM TL10MM IMPLANT HWC STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other