BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAYFUSE

    MDR report key: 902006 · Received August 21, 2007

    Report

    Report Number
    2030833-2007-00009
    Event Type
    Other
    Date Received
    August 21, 2007
    Date of Event
    August 8, 2007
    Report Date
    August 21, 2007
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K022726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING EXPLANTED DEVICE OR LOT INFORMATION. ADDITIONAL MODEL# STA-D8, ADDITIONAL CATALOG# STA-D8 AND ADDITIONAL LOT# K08484.

    Description of Event or Problem · 1

    THE ORIGINAL SURGERY WAS THE FIRST USE OF THE STAYFUSE DEVICE BY DR. THE SURGERY WAS IN 2007. (SALES REPRESENTATIVE) REPORTED THAT THE INSTALLATION OF THE STAYFUSE DEVICE WAS ACCORDING TO THE INSTRUCTION FOR USE AND THAT THE SNAP OF THE IMPLANT WAS AUDIBLE. FLUOROSCOPY CONFIRMED THAT THE INSTALLATION WAS CORRECT. A HARD-CASE SPLINT WAS APPLIED UNDER THE FOOT. DR. STATED THAT THE PATIENT WAS NON COMPLIANT DURING THE CONVALESCENCE. PATIENT PRESENTED FOR FOLLOW-UP 1 WEEK AFTER THE ORIGINAL SURGERY AFTER IMPLANTATION OF STAYFUSE DEVICE. AT THIS TIME, THE PATIENT REPORTED A CROOKED TOE. RADIOGRAPH AT FOLLOW UP REVEALED THAT THE STAYFUSE INTRAMEDULLARY FUSION DEVICE WHICH CONSISTS OF A PROXIMAL AND DISTAL PORTION SEPARATED. THE SURGEON ELECTED TO REMOVE THE IMPLANT AND REPLACE IT WITH ANOTHER STAYFUSE ONE WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAYFUSE INTRAMEDULLARY FUSION DEVICE HSB NEXA ORTHOPEDICS, INC. STA-P4 K08473

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R