BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVANNAH-T

    MDR report key: 7027087 · Received November 13, 2017

    Report

    Report Number
    1067095-2017-00020
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 13, 2017
    Report Date
    November 11, 2017
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    NKB
    PMA / PMN Number
    K132925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT STATED THAT DURING SURGERY, THE SAVANNAH-T FULLY SLOTTED SCREW BROKE WHILE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803110 SAVANNAH-T PEDICLE SYSTEM IMPLANT NKB SPINAL ELEMENTS 10-03-6545-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention