BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNAP ON SPHERZ

    MDR report key: 14986220 · Received July 12, 2022

    Report

    Report Number
    14986220
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    July 1, 2022
    Report Date
    July 1, 2022
    Manufacturer
    IZI MEDICAL PRODUCTS, LLC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SNAP-ON SPHERZ FOR STEALTH SPINE SURGERY. PRODUCT NOT FUNCTIONING PROPERLY. WHEN SNAPPED ONTO INSTRUMENTS, BREAKS OFF DURING CASE. PRODUCT ALSO SLIPPING OFF OF INSTRUMENTS. NO HARM: EVENT REACHED PATIENT, BUT NO HARM WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701547 SNAP ON SPHERZ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW IZI MEDICAL PRODUCTS, LLC PM8005 20221274

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Female