BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPHERZ PASSIVE REFLECTIVE MARKER

    MDR report key: 967050 · Received November 27, 2007

    Report

    Report Number
    967050
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 13, 2007
    Report Date
    November 27, 2007
    Manufacturer
    IZI MEDICAL PRODUCTS INC.
    Product Code
    FZZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE PLASTIC-LIKE COATING COVERING ONE OF THE SPHERZ PASSIVE REFLECTIVE MARKERS CAME OFF. THE PIECE OF COATING DID NOT FALL DIRECTLY INTO THE PATIENT'S OPEN WOUND, BUT DID FALL ON THE SURGICAL DRAPES COVERING THE PATIENT. THE PIECE OF COATING WAS PICKED OFF THE DRAPE AND REMOVED. THE SPHERZ MARKER THAT THE COATING FELL OFF OF WAS ALSO REMOVED. THE SURGICAL TEAM MEMBERS CHANGED THEIR GLOVES AND PROCEEDED WITH THE PROCEDURE. THERE WAS NO ADVERSE OUTCOME TO PATIENT. FIVE SEPARATE PACKAGES (EACH PACKAGE CONTAINS FIVE SPHERZ EACH) WERE OPENED FOR THE PROCEDURE AND ONLY 1 OF THE TOTAL OF 25 SPHERZ WAS NOTED TO HAVE A PROBLEM WITH THE COATING NOT ADHERED. PACKAGES WITH TWO DIFFERENT LOT NUMBERS WERE OPENED FOR THIS CASE AND SO IT WAS UNKNOWN FROM WHICH OF THE TWO LOT NUMBERS THE AFFECTED SPHERZ WAS FROM. A SURGICAL TEAM MEMBER RETURNED THE DEFECTIVE SPHERZ TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPHERZ PASSIVE REFLECTIVE MARKER MARKER, IMAGE GUIDED SURGERY FZZ IZI MEDICAL PRODUCTS INC. * 200715, BATCH 324245-1
    2 SPHERZ PASSIVE REFLECTIVE MARKERS MARKER, IMAGE GUIDED SURGERY FZZ IZI MEDICAL PRODUCTS INC * 200714; BATCH 323226-1

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR