BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 7908178 · Received September 25, 2018

    Report

    Report Number
    1030489-2018-01282
    Event Type
    Injury
    Date Received
    September 25, 2018
    Report Date
    September 25, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE U.S., HOWEVER A LIKE DEVICE WITH PART#: 8799025, 510K#: K994239 AND UPN (B)(4) IS CLEARED FOR US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE: ANTERIOR CERVICAL FUSION PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LOOSE SCREW OF PLATE IT WAS REPORTED THAT ON UNKNOWN DATE, POST-OP, DUE TO SCREW LOOSING THE PLATE WAS REMOVED IN THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745982 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention