BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2090128 · Received May 5, 2011

    Report

    Report Number
    9610622-2011-00209
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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

    THE PT UNDERWENT SURGERY WITH THE G3 LONG NAIL. WHEN THE SURGEON CONFIRMED THE X-RAY BECAUSE OF A FALL THE PT WAS X-RAYED AND IT WAS CONFIRMED THAT THE NAIL WAS BROKEN AT THE LAG SCREW HOLE. THE SURGEON REMOVED THE BROKEN NAIL AND THE PT UNDERWENT THE REVISION SURGERY WITH PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R1.5, TI, RIGHT 10X280MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K239767

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention