BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SYNEX II CENTRAL BODY

    MDR report key: 1982269 · Received January 26, 2011

    Report

    Report Number
    1719045-2011-00026
    Event Type
    Injury
    Date Received
    January 26, 2011
    Report Date
    November 29, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQP
    PMA / PMN Number
    K061891
    Removal / Correction Number
    Z-0108/18-2010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED. SYNTHES USA QUALITY COMPLAINT UNIT RECEIVED INFO FROM SYNTHES (B)(4) ON (B)(4) 2011. SYNTHES (B)(4) IS SUBSEQUENTLY SUBMITTING THIS 30 DAY NOTIFICATION BASED ON DATE OF AWARENESS AS (B)(4) 2011. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER. SYNEX II CENTRAL BODY DEVICES ARE CURRENTLY THE SUBJECT OF A MEDICAL DEVICE RECALL.

    Description of Event or Problem · 1

    SYNTHES (B)(4) REPORTED THAT A CUSTOMER IN (B)(6), IMPLANTED WITH SYNEX II AT T12-L2 ON (B)(6) 2008 AND VIVOSTAT BONE GRAFT EXPERIENCED COLLAPSE OF THE DEVICE. F/U X-RAYS WERE TAKEN (B)(6) 2008. THE COLLAPSE WAS NOTED BY X-RAY ON (B)(6) 2010 AND TWO OF THE CAUDAL 5.5MM TI CANCELLOUS LOCKING SCREWS OF THE ANTERIOR FIXATION (TSLP) WERE NOTED AS BROKEN. NO REVISION SURGERY HAS BEEN PLANNED. THIS IS THE 1ST OF 3 REPORTS SUBMITTED ON THIS EVENT.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention SCREWS