BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES, USA

    MDR report key: 511967 · Received February 19, 2004

    Report

    Report Number
    511967
    Event Type
    Injury
    Date Received
    February 19, 2004
    Date of Event
    December 30, 2003
    Report Date
    January 20, 2004
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2003, PT WITH A LONG STANDING HISTORY OF A PAINFUL RIGHT GREAT TOE WAS DIAGNOSED WITH PSEUDOARTHROSIS OF THE METATARSOPHALANGEAL JOINT RIGHT GREAT TOE. THEY UNDERWENT ARTHRODESIS WITH TRICORTICAL GRAFT FROM THE RIGHT ANTERIOR ILIAC CREST. A THREADED PIN, PLATE, AND 4 SCREWS WERE USED DURING THAT SURGERY. THEIR TOE HEALED UNEVENTUALLY BUT LATER THE PLATE BROKE AND THERE WAS OBVIOUS NON UNION OF THE ARTHRODESIS SITE. 4 MONTHS LATER SURGERY WAS PERFORMED TO REMOVE THE BROKEN PLATE AND OTHER HARDWARE THAT HAD BEEN INSERTED BEFORE. DURING SURGERY THE PLATE WAS FOUND BROKEN. SEVERAL OF THE SCREWS WERE QUITE LOOSE WITH FIBRINOUS MATERIAL AROUND THEM. THERE WAS A SIGNIFICANT AMOUNT OF SEROUS FLUID WITH FIBRINOUS MATERIAL THAT WAS PURULENT. THERE WAS NO EVIDENCE OF UNION OF THE GRAFT SITE. PT WAS DIAGNOSED WITH OSTEOMYELITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES, USA 1/4 TUBULAR, 7 HOLE PLATE HRS SYNTHES (USA) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization 2) THE 4 2.7 CORTEX SCREWS 12MM-202.012,| 14MM-202.014, 16MM-202.016.| 1) DEPUY 3/32 THREADED PIN 1653-15-000/805860000