BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6536059 · Received May 2, 2017

    Report

    Report Number
    1030489-2017-01069
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    April 7, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT IS UNKNOWN WHICH OF THE DEVICES LED TO THE EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES. FOLLOWING DEVICES WERE INVOLVED: PART#, LOT#, QTY, 510K#, UPN#: 876-142, UNK, 1, K081038 , (B)(4); 876-613, UNK, 6, K970806, (B)(4). (B)(4). 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT DEMOGRAPHY: ETHNICITY-CAUCASIAN IT WAS REPORTED THAT THE PATIENT UNDERWENT EXTRA PHARYNGEAL ANTEROLATERAL SURGERY AT C5-C6 AND C6-C7. POST-OP, DURING A ROUTINE VIS IT ON (B)(6) 2017 SITE REPORTED THAT THE PATIENT HAD SURGERY ON CERVICAL SPINE TO REMOVE DEVICE. THE PATIENT REPORTED MODERATE INTERMITTENT NECK PAIN THAT SHE TREATED WITH NORCO AND IBUPROFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318220 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R