BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SYNEX II CENTRAL BODY

    MDR report key: 1881091 · Received October 20, 2010

    Report

    Report Number
    1719045-2010-00300
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    June 16, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQP
    PMA / PMN Number
    K061891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE. DATE DEVICE WAS RETURNED TO SYNTHES (B)(4) IS UNKNOWN. UNABLE TO DETERMINE DEVICE MANUFACTURE DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PRODUCT WAS RETURNED TO SYNTHES (B)(4). PRODUCT EVALUATION COMPLETED BY SYNTHES (B)(4). THE MEASUREABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATIONS. REVIEW OF THE RAW MATERIAL TESTING CERTIFICATE AND MANUFACTURING RECORDS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH SPECIFICATIONS AND INTERNATIONAL STANDARD.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SYNEX II CENTRAL BODY (B)(6) 2009. X-RAYS TAKEN NOTED THAT THE INFERIOR PLATE OF SYNEX II CENTRAL BODY HAD SUNK. THE SUPERIOR PLATE WAS RELEASED, MOVING IN THE DIRECTION OF THE CORD WITHOUT NEUROLOGICAL ALTERATIONS. SYNEX II WAS REMOVED (B)(6) 2010, AND REPLACED WITH SYNEX I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI SYNEX II CENTRAL BODY SYNEX II CENTRAL BODY MQP SYNTHES MONUMENT NA 1998398

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention