BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT 10X280MM X 125

    MDR report key: 2132228 · Received June 14, 2011

    Report

    Report Number
    9610622-2011-00261
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 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 INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY WITH THE G3 LONG NAIL. ON (B)(6) 2011, WHEN THE PATIENT WAS ABOUT TO GET OUT OF THE CAR, HE FELT THE PAIN. THE SURGEON CONFIRMED BY X-RAY, THE NAIL WAS BROKEN IN THE LAG SCREW HOLE. ON (B)(6) 2011, THE SURGEON REMOVED THE BROKEN NAIL AND THE PATIENT UNDERWENT THE REVISION SURGERY WITH A G3 LONG NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, LEFT 10X280MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K108524

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention