BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 10X170MM X 125

    MDR report key: 1932922 · Received December 14, 2010

    Report

    Report Number
    9610622-2010-00556
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    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 AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT EVENT AS MDR 9610622-2010-00555.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT UNDERWENT SURGERY WITH THE G3 NAIL AND U-LAG SCREW. ON (B)(6) 2010, THE SURGEON FOUND THROUGH THE X-RAY THAT THE LAG SCREW CUT OUT FROM THE FEMORAL HEAD AND THE U-BLADE WAS BENDING. THEREFORE, THE PT UNDERWENT REMOVAL SURGERY AND HAD BHA REVISION SURGERY ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 10X170MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention