BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPINT STEREOTACTIC SYSTEM - BONE ANCHORS

    MDR report key: 5276829 · Received December 7, 2015

    Report

    Report Number
    3002250546-2015-00006
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 4, 2015
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT A PATIENT HAD ANCHORS FOR A STARFIX PLATFORM WERE INFECTED. CONCERNING THE BONE ANCHORS - THE PATIENT IS HEAVILY IMPAIRED DUE TO EXTREME UNCONTROLLED MOVEMENTS, SHE'S A (B)(6) PATIENT. THEREFORE, DR. THINKS THAT UNFORTUNATELY SHE DID TOUCH THE BONE ANCHOR INCISIONS OFTEN. THE WOUNDS DID SHOW SOME TRACES OF DIRT AS WELL. AFTER THE PLACEMENT OF THE SCREWS SHE WENT BACK TO THE NURSING HOME, THIS MIGHT ALSO BE ANOTHER FACTOR DUE TO LIMITED SUPPORT. TWO SCREWS DID SHOW PURULENCE AND DR. WAS CONCERNED ABOUT A CONTAMINATION INTO THE BRAIN. THAT'S WHY HE PREFERRED TO RESCHEDULED AND RESTART THE FULL PROCEDURE IN ORDER TO AVOID SERIOUS PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801916 WAYPINT STEREOTACTIC SYSTEM - BONE ANCHORS STEREOTACTIC SYSTEM HAW FHC, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization