BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 3920105 · Received July 8, 2014

    Report

    Report Number
    1030489-2014-03125
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQP
    PMA / PMN Number
    K041556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO TREAT LUMBAR DISC HERNIATION WITH IMPLANT OF A PEEK INTERBODY DEVICE. APPROXIMATELY 3 MONTHS POST-OP THE PATIENT COMPLAINED OF PAIN WHEN LYING DOWN AND WHILE MOVING THE LEG. NO MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396039 VERTE-STACK SPINAL SYSTEM SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDTRONIC SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR Other