BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES

    MDR report key: 974910 · Received December 7, 2007

    Report

    Report Number
    MW4004317
    Event Type
    Other
    Date Received
    December 7, 2007
    Date of Event
    November 8, 2007
    Report Date
    November 21, 2007
    Manufacturer
    SYNTHES USA
    Product Code
    JDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD FUSION WITH POSTERIOR FIXATION FOR FAILED PRIOR FUSION AND MRSA INFECTION. THE RODS WERE NOTED TO BE BROKEN AND PT HAD PAIN AND CREPITUS FROM BROKEN RODS RUBBING TOGETHER. PT HAD REMOVAL AND REFUSION OF NONUNION IN 2007. IN LIGHT OF PT'S CLINICAL SETTING, THIS IS INERTPRETED BY ME AS A FAILURE OF THE PT'S BIOLOGY, NOT A FAILURE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES USS DUAL OPENING SYSTEM, 6MM OR 1/4 INCH TITANIUM ROD JDN SYNTHES USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other