BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONSTRUCTION NAIL R1.5, TI, LEFT 11X380 MM X 12

    MDR report key: 2170060 · Received July 13, 2011

    Report

    Report Number
    9610622-2011-00308
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 21, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K102992
    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

    ON (B)(6) 2011, THE PT UNDERWENT SURGERY WITH THE T2 RECON NAIL. AFTERWARDS, BECAUSE THE CALLUS WAS CONFIRMED IN THE FRACTURE PART, THE PT LEFT HOSPITAL. ON (B)(6) 2011, THE PT FELT THE PAIN. THE SURGEON CONFIRMED BY X-RAY, NAIL WAS BROKEN IN THE LAG SCREW HOLE. ON (B)(6) 2011, THE SURGEON REMOVED THE BROKEN NAIL AND THE PT UNDERWENT REVISION SURGERY WITH A STAINLESS NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECONSTRUCTION NAIL R1.5, TI, LEFT 11X380 MM X 12 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K135732

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention