BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2202582 · Received August 8, 2011

    Report

    Report Number
    9610622-2011-00352
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 19, 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

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

    Description of Event or Problem · 1

    THIS EVENT IS THE SAME PT AS (B)(4). ON (B)(6) 2009, THE PT UNDERWENT THE REVISION SURGERY WITH THE GAMMA3 LONG NAIL. ON (B)(6) 2011, THE SURGEON FOUND THROUGH THE X-RAY THAT THE NAIL WAS BROKEN IN THE PART OF LAG SCREW HOLE. THERE WAS NO PROBLEM IN THE POSTOPERATIVE PROGRESS. THE SURGEON IS PLANNING REVISION SURGERY IN (B)(6) 2011. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN GAMMA3 LONG NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, LEFT 10X340MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K247069

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention