BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6705056 · Received July 12, 2017

    Report

    Report Number
    1030489-2017-01731
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 13, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    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 PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 876-713, 510K# K970806 AND UDI (B)(4) IS APPROVED FOR SALE IN US. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH CERVICAL SPONDYLOTOIC MYELOPATHY AND OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT UNDERWENT C4-7 CERVICAL FUSION. ON (B)(6) 2017, POST-OP, THE C7 SCREWS BACKED OUT WITH THE PLATE. AS A RESULT, A REVISION SURGERY WAS PERFORMED TO EXPLANT THEM. PROLONGATION OF EXISTING HOSPITALIZATION WAS NECESSARY DUE TO REVISION SURGERY.IT WAS CONFIRMED THAT THE PLATE ROCK WAS ON AT REMOVING SCREWS. DOCTOR STATED THAT THE COLLAR FOR AFTER TREATMENT WAS NOT DONE, WHICH MAY BE ONE OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485836 ATLANTIS® ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5191565

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention