BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2061284 · Received April 12, 2011

    Report

    Report Number
    2520274-2011-00085
    Event Type
    Injury
    Date Received
    April 12, 2011
    Report Date
    March 20, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH CLICK'X 2 YEARS PRIOR. POSTERIOR FIXATION REVISION TO EXTENDED CONSTRUCT IN 2010. TUMOR IN VERTEBRAL BODY AND RESECTION AT T5 WITH CEMENT. SCREWS, RODS AND LOCKING CAPS ADDED AT T3 AND T4 TO EXTEND CONSTRUCT FROM T3-T9 AND CONNECT PREVIOUS RODS AT T8-T9. SCREWS REMOVED AT T5, NEW RODS AND CONNECTORS ADDED AT T8. SYNEX II AT T5-T8 AND T12 WERE FINE. PATIENT REVISED. X-RAYS SHOWED TUMOR ERODED BONE AND SYNEX II SUBSIDED. TWO SCREWS WERE PUSHING THROUGH SKIN AT T9 RIGHT AND LEFT. ROD BROKE AT T8 ON RIGHT. SYNEX II AT T6-T7 REMOVED ANTERIORLY (B)(6) 2011. PATIENT REVISED. RODS REPLACED AND SCREWS REMOVED AT T8 WITH CORPECTOMY ON (B)(6) 2011. PATIENT REVISED TO POSTERIOR FUSION ON (B)(6) 2011 AT T3-L2. THIS IS THE 2ND OF 16 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI CLICK'X SCREW KWP SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention CONNECTORS| SYNEX II| SCREWS| 3D HEADS| LOCKING CAPS