BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL DUEL CORE SCREW

    MDR report key: 3003476 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10363
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO DEVICE HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE NO LOT NUMBER WAS REPORTED. THE SAMPLE WAS EVALUATED AND PART NUMBER WAS IDENTIFIED, MECHANICAL INSPECTION REVEALED NO ISSUE WITH THE SCREW. CONCLUSION: COMPLAINT WAS DETERMINED TO BE INVALID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF PLIF L4-L5, THE MATRIX REDUCTION HEAD POPPED OFF AFTER IT WAS PLACED ON L4. THE SURGEON INSERTED SCREWS AT L4. PLACED SIMPLE STANDARD POP ON HEAD L5, AND USED REDUCTION POP ON HEAD ON L4. HE TESTED IT WITH POP-ON TOOL, AT WHICH POINT IT WAS SECURELY ATTACHED. THE SURGEON THEN PUT THE ROD INTO THE SCREW HEAD, PUT ON THE CAP ON L5 AND L4. JUST AS HE TIGHTENED THE SCREW, THE REDUCTION HEAD OF L4 POPPED OFF. PROCEDURE WAS COMPLETED BY PULLING OUT THE SCREW ON L4 AND REPLACING THEM. NO BROKEN PIECES WERE PRESENT AND NO PT HARM WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87018 POLYAXIAL DUEL CORE SCREW HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1