BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 14345108 · Received May 10, 2022

    Report

    Report Number
    1030489-2022-00454
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 10, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A SIMILAR DEVICE WITH PRODUCT ID: 8799130 WITH 510(K) # K994239 IS MARKETED IN US. PRODUCT CODE OF SIMILAR DEVICE WITH PRODUCT ID: 8799130. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT REVISION SURGERY FOR REMOVING THE SCREW/PLATE DUE TO SCREW-BACK-OUT AT C5/6. IT WAS REPORTED THAT THE C6 LEFT SCREW WAS BACKED-OUT DUE TO THE BROKEN C6 LEFT SCREW STOPPER AND WAS REMOVED. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE IMPLANT DATE AND EXPLANT DATE OF SCREW IS (B)(6) 2011 AND (B)(6) 2022. THE SCREW WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593071 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD KWQ WARSAW ORTHOPEDICS G8799130 0067471W

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention