BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3232477 · Received July 18, 2013

    Report

    Report Number
    1030489-2013-03056
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K970806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. (B)(6). (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. DEVICES OF MULTIPLE PART NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 976-140 / LOT: UNKNOWN (X1) - 40MM ANTERIOR CERVICAL PLATE PART: 876-814 / LOT: UNKNOWN (X5) - 4.0 SELF-TAP SCREWS ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTROL PATIENT IN A CLINICAL STUDY UNDERWENT AN "EXTRAPHARYNGEAL ANTEROLATERAL" SURGERY AT C5-C6 AND C6-C7. ACCORDING TO THE REPORT,"60 MONTH FILMS SHOWED MINIMAL, ONE-TURN, BACK OUT OF CAUDAL SCREW WHICH WAS STABLE. THE PATIENT WAS ESSENTIALLY ASYMPTOMATIC, REGARDING [PATIENT'S] NECK." IT IS UNKNOWN IF FUSION OCCURRED FOR THE PATIENT. NO TREATMENT WAS PROVIDED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335900 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWQ MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR ANTERIOR CERVICAL PLATE 976-140, SCREWS (X5)