BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7595561 · Received June 13, 2018

    Report

    Report Number
    1030489-2018-00843
    Event Type
    Injury
    Date Received
    June 13, 2018
    Report Date
    June 13, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE DEVICES WERE IMPLANTED DURING THE PROCEDURE, DETAILS OF WHICH HAS BEEN PROVIDED BELOW: CATALOG NO.: 976-145, LOT NO.: UNK, QTY: 01, UDI: (B)(4), 510(K): K021461, PRODUCT CODE: (B)(4), CATALOG NO.: 876-813, LOT NO.: UNK, QTY: 04, UDI: (B)(4), 510(K): K970806, PRODUCT CODE: (B)(4), CATALOG NO.: 976-145, LOT NO.: UNK, QTY: 02, (B)(4), 510(K): K970806, PRODUCT CODE: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THE REPORTED DEVICES LED TO THE EVENT OR NOT, WE ARE FILLING THIS REPORT FOR NOTIFICATION PURPOSES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT C5-6 AND C6-7 ANTERIOR CERVICAL DISCECTOMY AND FUSION DUE TO C5-6 AND C6-7 DISK HERNIATION WITH BILATERAL UPPER EXTREMITY RADICULOPATHY. REPORTEDLY POST-OP, THE PATIENT HAD SWELLING AND PAIN SINCE TWO WEEKS AFTER SURGERY. THE PATIENT IS ALSO EXPERIENCING THE FOLLOWING COMPLICATIONS: RESPIRATORY PROBLEMS, RASH, TROUBLE SWALLOWING, BRONCHITIS, INFLAMMATION THROUGHOUT BODY, LUPUS, GASTRITIAL PROBLEMS, VISUAL PROBLEMS, LOSS OF HEAD MOVEMENT, DYSPHONIA, FLUID COLLECTION AROUND NECK, SHOULDER, LEG, MUSCLE SPASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437573 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other