BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCENT

    MDR report key: 7475315 · Received April 30, 2018

    Report

    Report Number
    MW5076925
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    April 4, 2018
    Report Date
    April 27, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A POSTERIOR SPINAL FUSION LUMBAR OR THORACIC SURGERY. DURING THE SURGERY THE SURGEON USED A INTERBODY SPACER AND THE TONG ON THE CAGE INSERTER BROKE OFF INSIDE THE PATIENT. X-RAY CONFIRMED THE TONG WAS LEFT INSIDE PATIENT. TONG WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314438 LUCENT INTERVERTEBRAL FUSION DEVICE - LUMBAR MAX SPINAL ELEMENTS 10010-000 070730

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization