BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 7387526 · Received March 31, 2018

    Report

    Report Number
    1030489-2018-00505
    Event Type
    Injury
    Date Received
    March 31, 2018
    Date of Event
    December 10, 2012
    Report Date
    March 31, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 876-813, QTY: 6, 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

    TYPE OF PROCEDURE: ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) TYPE OF APPROACH: EXTRAPHARYNGEAL ANTEROLATERAL LEVELS IMPLANTED: C4-C5 AND C5-C6 IMPLANT DATE: (B)(6) 2006 IT WAS REPORTED VIA CLINICAL STUDY THAT ON (B)(6) 2012, APPROXIMATELY 75 MONTHS POSTOPERATIVELY, DURING A ROUTINE VISIT, THE PATIENT HAD A CERVICAL DISC HERNIATION AT C6-C7. SHE WAS DIAGNOSED WITH CERVICAL DISC HERNIATION C6-C7 WITH INTRACTABLE RADICULOPATHY WITH PREVIOUS HARDWARE C4 TO C6 FROM AN ACDF. THE PATIENT UNDERWENT HARDWARE REMOVAL AT C4 TO C7 AND EXPLORATION OF FUSION C4-C6 (SOLID FUSION WAS FOUND); ANTERIOR CERVICAL DISCECTOMY C7; FORAMINOTOMY LEFT AND RIGHT SIDE C6-C7; ANTERIOR INTERBODY FUSION WITH LEFT CORTICAL CANCELLOUS ALLOGRAFT; AND ANTERIOR INSTRUMENTATION C6-C7. THE STUDY SITE NOTED THAT THE SURGERY ¿WENT WELL¿, AND THE PATIENT WAS STILL IN FOLLOW UP, HOWEVER, THE CERVICAL DISC HERNIATION WAS RESOLVED BY THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230304 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention