BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEUS A

    MDR report key: 7733637 · Received July 30, 2018

    Report

    Report Number
    1067095-2018-00006
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 24, 2018
    Report Date
    July 24, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    MAX
    PMA / PMN Number
    K081614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RADIOGRAPHS OR IMAGES, PART NUMBER, LOT NUMBER,OR ANY CLARIFYING DETAILS WERE PROVIDED. THE SPECIFIC FAILURE MODE, "INSTRUMENTATION WAS DETACHED" IS NOT CLEARLY UNDERSTOOD. NO FURTHER INFORMATION WAS ABLE TO BE RECEIVED. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTEDLY THE INITIAL SURGERY DATE WAS (B)(6) 2017, INVOLVING ANTERIOR LUMBAR INTERBODY FUSION AT L5-S1. ALLEGEDLY THE "INSTRUMENTATION WAS DETACHED". NO FURTHER DETAILS ABOUT THE EVENT OR THE PATIENT CONDITION WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573174 ZEUS A INTERVERTEBRAL FUSION DEVICE MAX SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1