BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125

    MDR report key: 2885227 · Received December 18, 2012

    Report

    Report Number
    9610622-2012-00585
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    April 30, 2012
    Report Date
    December 4, 2012
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE INFORMATION RECEIVED, THE DEVICES ARE NOT AVAILABLE AT THIS TIME DUE TO ON GOING LITIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED BY ATTORNEY OF THE PT, THAT THE GAMMA NAIL BROKE IN (B)(6) 2012. A REVISION SURGERY TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K912602

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R