BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 451362 · Received March 20, 2003

    Report

    Report Number
    MW1028008
    Event Type
    Malfunction
    Date Received
    March 20, 2003
    Date of Event
    March 8, 2002
    Report Date
    March 20, 2003
    Manufacturer
    INTERPACE CROSS INTERNATIONAL
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD SPINE INSTRUMENTATION AND FUSION OF RIGHT THORACIC SCOLIOSIS IN 2001. IN 03/2002 THE PT FELT A SNAP IN BACK. X-RAYS IN 03/2002 SHOWED DISCONNECTION OF UPPER HOOK ON RIGHT AND SUBSEQUENTLY LOW HOOK ALSO. REPEAT SURGERY DONE IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY 1/4" STAINLESS STEELRODS KWQ INTERPACE CROSS INTERNATIONAL * *
    2 SYNERGY HOOKS MNH INTERPACE CROSS INTERNATIONAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other