BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1348882 · Received March 19, 2009

    Report

    Report Number
    2520274-2009-00044
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    July 31, 2006
    Report Date
    July 30, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. CANNOT BE DETERMINED WITHOUT A CATALOG NUMBER. INVESTIGATION COULD NOT BE CONCLUDED. NO CONCLUSION COULD BE DRAWN. REVIEW OF MANUFACTURING RECORDS COULD NOT BE REQUESTED WITHOUT A LOT NUMBER. NOTE: THE COMPLAINT HANDLING UNIT (CHU) RECEIVED A FACT SHEET FROM THE PRODUCT LIABILITY GROUP ON FEBRUARY 19, 2009. THE INFO ON THE FACT SHEET WAS NOTED AS BEING RECEIVED ON 07/30/08 BY PRODUCT LIABILITY. THE CHU IS SUBSEQUENTLY SUBMITTING THIS 30 DAY NOTIFICATION BASED ON THE INFO RECEIVED ON FEBRUARY 19, 2009.

    Description of Event or Problem · 1

    DURING A L5-S1 DISKECTOMY AND INTERBODY FUSION, PT WAS IMPLANTED WITH AN ATB PLATE AND 5.5MM TI CANCELLOUS SCREWS. AN X-RAY TAKEN 3 WEEKS POST OPERATIVE REVEALED, SCREW BREAKAGE AT S1 AND ENTIRE CONSTRUCT HAS SLID. PT WITH UNSTABLE L5-S1 ISTHMIC SPONDYLOLISTHESIS UNDERWENT PROCEDURE FOR L4-S1 PEDICLE SCREW INSTRUMENTATION, POSTEROLATERAL FUSION, OPEN REDUCTION L5-S1 SPONDYLOLISTHESIS, WITH RIGHT ILIAC CREST BONE GRAFT WITH PLANNED REMOVAL OF INSTRUMENTATION AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NI HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention SCREWS| PLATE