BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, RIGHT 10X340MM X 125

    MDR report key: 2161204 · Received July 8, 2011

    Report

    Report Number
    9610622-2011-00303
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PT UNDERWENT THE SURGERY WITH THE T2 RECON NAIL. AFTERWARDS, THE T2 RECON NAIL WAS BROKEN. ON (B)(6) 2010, THE SURGEON REMOVED THE BROKEN T2 RECON NAIL AND THE PT UNDERWENT THE REVISION SURGERY BY THE G3 LONG NAIL. HOWEVER, THE G3 LONG NAIL WAS BROKEN. THEREFORE, THE SURGEON REMOVED THE BROKEN G3 NAIL AND THE PT UNDERWENT THE REVISION SURGERY BY THE CHS ON (B)(6) 2011. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN G3 NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, RIGHT 10X340MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K150083

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention