BEUDAMED
    FDA Adverse Event Other Summary report: N

    XIA ROD DIA. 6 X 480

    MDR report key: 2100705 · Received May 18, 2011

    Report

    Report Number
    9617544-2011-00178
    Event Type
    Other
    Date Received
    May 18, 2011
    Date of Event
    November 10, 2008
    Report Date
    April 19, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K984251
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HISTORY ANALYSIS, MFG RECORD REV, RISK ASSESS. REV. RESULTS: TWO SCREWS AND TWO BLOCKERS WERE RECEIVED, NO RODS WERE RETURNED. VISUAL INSPECTION ON SCREWS SHOWED NO DAMAGE. BLOCKERS HAD ONE SINGLE MARK FROM CONTACT PRESSURE ON ROD WHERE TWO ARE USUALLY PRESENT FOR NORMAL TIGHTENING. DEFORMATION ON BLOCKERS SUGGESTS ROD WAS SHORT IN TULIP CAUSING DISSYMMETRIC CONTACT, THUS UNEVEN LOAD OF BLOCKER ON ROD, SUGGESTING ROD WAS NOT FULLY PASSED THROUGH TULIP RESULTING IN NON-OPTIMALLY LOCKED CONSTRUCT. COMPLAINT HISTORY ANALYSIS-FROM (B)(6), ABOUT FIFTY COMPLAINTS HAVE BEEN RECEIVED INVOLVING LOOSENING OF BLOCKERS. CAUSE IS USUALLY SURGICAL TECHNIQUE, IMPROPER TIGHTENING OR ROD CONFIGURATION. MFG RECORD REV.-MFG RECORDS WERE REVIEWED FOR SCREWS AND BLOCKERS - NO RELEVANT DEVIATIONS WERE REPORTED. RISK ASSESS. REV. -THIS ISSUE CAN EXPOSE PATIENT TO RISK ASSOCIATED WITH REVISION FOR THE CORRECT FIXATION OF DEVICES. CONCLUSIONS: BASED ON ABOVE INFORMATION, IT IS PRESUMED THAT NON-OPTIMAL ROD CONFIGURATION IN TULIP LED TO POOR CONNECTION STRENGTH. AS WRITTEN IN THE XIA SURGICAL TECHNIQUE EXTRA CAUTION IS ADVISED IF THE ROD IS NOT HORIZONTALLY PLACED OR HIGH IN THE TULIP SLOT.

    Description of Event or Problem · 1

    WE RECEIVED THE SCREWS WITH CAPS BACK FROM (B)(6) WITH REPORT FORM TO THE (B)(6) DATED (B)(6) 2008. NO EXISTING PER WAS FOUND. CONTACTED SALES REP, (B)(4). HE FOUND OUT THE FOLLOWING: IN 2008 THE HEAD SURGEON, PROF. (B)(6) (NOW RETIRED), INFORMED AGES AND SENT THE PRODUCTS TO AGES, BUT DID NOT INFORM THE MANUFACTURER. AT SOME POINT AGES RETURNED THE PRODUCTS TO THE PHARMACY OF THE (B)(6), WHERE THEY WERE PLACED INTO STORAGE. NOW THE PHARMACY IS CLEANING UP ITS STORAGE AND RETURNED THEM TO THE MANUFACTURERS. THE ONLY INFO WE HAVE IS WHAT IS STATED ON THE FORM: TOO LOOSE CONNECTION BETWEEN SCREWS AND ROD ALTHOUGH THE SCREW CAP WAS FASTENED WITH 12 NM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA ROD DIA. 6 X 480 IMPLANT KWQ STRYKER SPINE BORDEAUX NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R 2 XIA B| 2 XIA LP MONOAXIAL SCREW: CAT#03820650| LOT# A73056