BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7654756 · Received July 2, 2018

    Report

    Report Number
    1030489-2018-00940
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    August 19, 2011
    Report Date
    July 2, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 976-142, QTY: 1, UDI: (B)(4), 510(K): K021461; AND PRODUCT ID: 876-816, QTY: 4, UDI: (B)(4), 510(K): K970806. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    OPERATIONAL APPROACH: EXTRAPHARYNGEAL ANTEROLATERAL LEVELS OF OPERATION: C5-C6, C6-C7 IT WAS REPORTED VIA CLINICAL STUDY THAT ON (B)(6) 2007, THE PATIENT UNDERWENT CERVICAL FUSION. POST-OP, ON (B)(6) 2011, THE PATIENT EXPERIENCED DYSPHAGIA AND DIFFICULTY SWALLOWING. ON (B)(6) 2011, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY (TRANSNASAL FIBEROPTIC LARYNGOSCOPY) DUE TO THIS EVENT. THE PATIENT ALSO PRESENTED FOR AN OFFICE VISIT ON (B)(6) 2017. AFTER 120 MONTH FOLLOW-UP VISIT, THE PATIENT CAN SWALLOW WITHOUT DIFFICULTY. THE ADVERSE EVENT HAS NOW BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496256 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention