BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPEDSCHANZSCR Ø6.2 L190/45 TAN DBLUE

    MDR report key: 2983417 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-00689
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS COMPLAINT IS FOR 3 PARTS WITH THE SAME PART AND LOT NUMBER. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS CONDUCTED AND IT STATES THAT THE CLAMP DOES NOT FIT OVER THE TRANSPEDICULAR SCHANZ SCREWS. THE SCREW WAS MEASURED AND FOUND TO BE MANUFACTURED NOT ACCORDING TO THE PRINT SPECIFICATIONS. THE MANUFACTURING FAILURE OCCURRED THROUGH OUT THE TURNING PROCESS. IF THE CUTTING TOOL GETS WORN OUT AFTER A CERTAIN TIME THE CUTTING PRESSURE DOES INCREASE AND MY LEAD TO SUCH FAILURES, WHERE THE MATERIAL WAS NOT ENOUGH CUT AWAY. FURTHERMORE, AN INTERNAL EVALUATION WAS CONDUCTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY DURING A PROCEDURE ON (B)(6) 2013 TO REPAIR A L2 CHANCE FRACTURE AFTER THE SCREW INSERTION THE SURGEON ATTEMPTED TO INSERT A CLAMP OVER THE SCHANZ SCREW CONSTRUCT BUT WAS UNSUCCESSFUL. THE SURGEON THEN TRIED TO REPLACE THE SCREW WITH ANOTHER SCREW OF THE SAME SIZE BUT THE CLAMP WOULD NOT GO THROUGH THE SCREW. REPORTEDLY IN TOTAL THE SURGEON ATTEMPTED WITH 3 SCREWS AND THEY WERE ALL INEFFECTIVE. THE SURGEON CHANGED THE SIZE OF SCREWS AND CONTINUED WITH THE SURGERY. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86152 TRANSPEDSCHANZSCR Ø6.2 L190/45 TAN DBLUE TRANSPED SCHANZ SCREW HWC SYNTHES GMBH 8123409

    Patients

    Seq Age Sex Outcome Treatment
    1