BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM SCREW, STRYKER LEIBINGER MICRO IMPLANT

    MDR report key: 17526118 · Received August 12, 2023

    Report

    Report Number
    MW5133058
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    September 24, 2015
    Manufacturer
    STRYKER
    Product Code
    HWC
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AUFFARTH, A. ET AL. (2008). "MINIMALLY-INVASIVE TREATMENT OF THREE- AND FOUR-PART FRACTURES OF THE PROXIMAL HUMERUS IN ELDERLY PATIENTS". THE JOURNAL OF BONE AND JOINT SURGERY (BR), 90-B: 1602- 7 REPORTED THAT THREE HUNDRED AND TWENTY-FIVE FRACTURES WERE TREATED BY PERCUTANEOUS REDUCTION AND MINIMALLY INVASIVE FIXATION USING HUMERUSBLOCK TECHNIQUE. THE DEVICE CONSISTS OF A METAL BLOCK WHICH IS FIXED TO THE HUMERAL SHAFT BY A CANNULATED CORTICAL SCREW. TWO CROSSED KIRSCHNER- WIRES HOLDING THE HEAD FRAGMENT ARE PASSED THROUGH THE BLOCK AT AN ANGLE OF FORTY FIVE DEGREES AND ARE HELD IN PLACE BY A LOCKING SCREW. THE BLOCK IS FIXED TO THE HUMERAL SHAFT BY A CANNULATED CORTICAL SCREW. IF NEEDED ONE OR MORE 2.7MM TITANIUM COMPETITORS SCREWS ARE INSERTED TO HOLD THE GREATER TUBEROSITY. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762981 TITANIUM SCREW, STRYKER LEIBINGER MICRO IMPLANT SCREW, FIXATION, BONE HWC STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown