BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VEPTR

    MDR report key: 1665231 · Received April 14, 2010

    Report

    Report Number
    1665231
    Event Type
    Malfunction
    Date Received
    April 14, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 14, 2010
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    MDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    VEPTR (VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB) HOOK THAT WAS IMPLANTED IN PREVIOUS SURGERY BROKE. THE FRACTURE HOOK WAS REMOVED IN ITS ENTIRETY. A NEW ILIAC HOOK WAS PLACED AND SEATED. IT WAS ATTACHED TO THE ROD WITH THE NEW DOMINO, AND GENTLE DISTRACTION WAS USED TO RESTORE AND EXPAND THE THORACIC CAGE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================IT IS STATED THIS IS AN UNUSUAL SITE FOR HARDWARE TO FRACTURE. THE HOOK FRACTURE WAS AT THE CONNECTION POINT OF THE DOMINO CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEPTR S HOOK - LEFT MDI SYNTHES (USA) PRODUCTS LLC * NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *