BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 7057631 · Received November 24, 2017

    Report

    Report Number
    1030489-2017-02384
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    May 30, 2017
    Report Date
    November 24, 2017
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 8799150, 510K# K994239 AND UPN (B)(4) IS CLEARED FOR US. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION SURGERY AT C5-C7 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY (CSM). POST-OP, AIRWAY OBSTRUCTION WAS DEVELOPED DUE TO HEMATOMA. HENCE, PATIENT UNDERWENT TRACHEOSTOMY. IMPLANTED PLATE AND SCREW WERE FOUND LOOSE AND UNSUCCESSFUL BONE UNION WAS ALSO OBSERVED POST-OPERATIVELY. PATIENT WAS SCHEDULED FOR INTERVENTION, HOWEVER, DUE TO PATIENT'S PHYSICAL CONDITION IT WAS POSTPONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836557 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA 0322271W

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R