BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 698609 · Received April 7, 2006

    Report

    Report Number
    1030489-2006-00093
    Event Type
    Injury
    Date Received
    April 7, 2006
    Date of Event
    March 7, 2006
    Report Date
    March 13, 2006
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    LYQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONSTRUCT WAS EXPLANTED DUE TO DEEP INFECTION. DURING THE EXPLANTATION THE SURGEON ABSERVED THAT SOME CONNECTORS HAD COME OFF THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM SPINAL FIXATION SYSTEM LYQ WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention