BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIAX

    MDR report key: 8639811 · Received May 24, 2019

    Report

    Report Number
    8639811
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    May 9, 2019
    Report Date
    May 17, 2019
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A LEFT WRIST ARTHRODESIS PROCEDURE PERFORMED ON [DATE REDACTED] WITH AUTOLOGOUS BONE GRAFT AND FIXATION USING A STRYKER WRIST FIXATION PLATE. THE PATIENT RETURNED FOR EVALUATION ~3 YEARS LATER CITING TWO WEEKS OF INCREASING LEFT WRIST PAIN AND SWELLING ON THE LEFT DORSAL DISTAL FOREARM AND DORSAL WRIST. THE PATIENT ALSO NOTED NUMBNESS OF THE INDEX, MIDDLE AND RING FINGER. AN X-RAY REVEALED FRACTURE OF THE RADIAL METACARPAL PLATE THROUGH THE SCREW HOLE AT THE CARPAL METACARPAL JOINT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM 6 DAYS LATER FOR REMOVAL OF THE BROKEN PLATE AND 8 SCREWS. A BONE GRAFT WAS COMPLETED. THE PATIENT WILL HAVE A CAST FOR 4-6 WEEKS AND LIMITED LIFTING CAPABILITY. THERE WAS NO PATIENT FALL OR TRAUMA THAT COULD BE ATTRIBUTED TO THE PLATE FRACTURE. THE SURGEON THOUGHT THAT THE PLATE BREAKAGE WAS METAL FATIGUE LIKELY DUE TO MICROMOTION OF THE MIDDLE FINGER (3RD DIGIT) CARPOMETACARPAL (CMC) JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434339 VARIAX PLATE, FIXATION, BONE HRS STRYKER TRAUMA SA 629590 4002065

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA Hospitalization| O| R| S