BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 5969428 · Received September 22, 2016

    Report

    Report Number
    1030489-2016-02626
    Event Type
    Malfunction
    Date Received
    September 22, 2016
    Date of Event
    August 30, 2016
    Report Date
    August 30, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    N/A
    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 USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 876-014, 510K # K970806 WAS CLEARED IN THE UNITED STATES. (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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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) 2016, PATIENT UNDERWENT ANTERIOR CERVICAL FUSION FOR PRE-OP DIAGNOSIS AS FRACTURE-DISLOCATIONS AT LEVELS C6-C7. ON AN UNKNOWN DATE, POST-OP, LEFT C6 SCREW WAS BACKED OUT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016, TO REPLACE THE SCREW AND FIXATION LEVEL WAS EXTENDED TO C5. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622009 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention