BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 8098764 · Received November 22, 2018

    Report

    Report Number
    1030489-2018-01526
    Event Type
    Injury
    Date Received
    November 22, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 22, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# 876-013 AND 510K# K970806 AND UDI# (B)(4) IS APPROVED FOR SALE IN THE 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION OF 2 INTERVERTEBRAL DISCS. POST-OP, APPROXIMATELY ON (B)(6) 2018, ONE OF THE SIX SCREWS OF ARTIFICIAL PLATE WAS FOUND TO HAVE BACKED OUT. A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2018, IN WHICH THE DISLODGED SCREW WOULD BE REMOVED. THE PATIENT HAS ACHIEVED SOLID FUSION. NO INFORMATION IS AVAILABLE IF THE REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938087 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention