BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT 11X360MM X 125

    MDR report key: 1931540 · Received December 9, 2010

    Report

    Report Number
    9610622-2010-00523
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 25, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    SURGEON REPORTED, VIA SALES REP, THAT THE NAIL BROKE. NO FURTHER INFO WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, RIGHT 11X360MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K262630

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention