BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW HEAD POLYAX F/MATRIX 5.5 TAN

    MDR report key: 3163645 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03252
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 14, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    UNABLE TO UNLOCK, LOCKING CAPS. DOCTOR NOTED ON FINAL CHECK X-RAY OF THE MATRIX POLYAXIAL HEADS THE HEADS WERE NOT CONNECTED TO THE MATRIX BONE SCREW. THE DOCTOR STATED HE FELT HE HAD CONNECTED CORRECTLY (INCLUDING REAMING AROUND THE BONE SCREW) AND SAID IT DID NOT FEEL ANY DIFFERENT DURING FINAL TIGHTENING. THE DOCTOR THEREFORE HAD UNLOCKED THE CONSTRUCT TO REATTACH THE HEAD. IN THE PROCESS TWO OF LOCKING CAPS WHICH HAD BEEN FINAL TIGHTENED COULD NOT BE REMOVED. THE DOCTOR WAS INSTRUCTED TO USE THE PERSUADER AS A COUNTER TORQUE WITH THE TORQUE HANDLE, AND THIS DID UNLOCK THE CAP. THE DOCTOR WISHES TO MAKE A COMPLAINT ABOUT THE HEAD NOT ENGAGING, HOWEVER THE DOCTOR WAS MORE CONCERNED ABOUT THE DIFFICULTLY IN UNLOCKING THE SET SCREWS. THIS IS 1 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263699 SCREW HEAD POLYAX F/MATRIX 5.5 TAN NKB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1