BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 3171591 · Received June 15, 2013

    Report

    Report Number
    2530088-2013-00920
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    November 23, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. (B)(6). THE DESCRIBED MALFUNCTIONS SUBSTANTIATE THAT FOR ONE OF THE SCREWS, THE THREAD OF THE PRIME LOCK FEATURE IS BROKEN AND FOR THE OTHER TWO SCREWS, THE COLLET INSIDE THE HEAD IS TWISTED AND JAMMED. THE CAUSE OF THE DAMAGE OF PRIME LOCK FEATURE IS UNKNOWN, BUT IS INDICATIVE OF EXCESSIVE TENSION IN COMBINATION WITH HIGH SIDEWAY PRESSURE (ON THE SOFT PART SIDE) ON THE SCREW. THE TWISTING PROBLEM OF THE COLLET WAS ALREADY ANALYZED IN DETAIL DUE TO PREVIOUS COMPLAINTS AND A CORRESPONDING IMPROVEMENT MEASURE WAS ALSO INTRODUCED. IT IS RECOMMENDED TO ADJUST THE POLYAXIAL HEADS WITH THE HEAD ADJUSTMENT INSTRUMENT (03.632.007), IN ORDER TO PREVENT THE TWISTING OF THE COLLET (SEE OP-TECHNIC 016.001.185). THE DEVICES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THERE ARE NO PRODUCTION ERRORS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING USE ON AN UNKNOWN DATE, ADJACENT SOFT PARTS WERE SUBJECTED TO HEAVY TENSION WHEN THE PEDICLE SCREW WAS SCREWED IN. WHEN THE SCREWS THAT WERE PROPERLY ATTACHED TO THE SCREWDRIVER WERE SCREWED INTO THE BONE, THE SCREW DISENGAGED FROM THE SCREWDRIVER AND THE POLYAXIAL HEAD CAME OFF OF THE BONE SCREW. THE PRIMELOCK THREAD WAS STRIPPED OUT. THE COLLET IN THE POLYAXIAL HEAD OF TWO OTHER 7X50MM SCREWS IS TWISTED. ONE 5MM SCREW HAS LOST ITS POLYAXIALITY. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272602 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM NKB SYNTHES BRANDYWINE 6729900

    Patients

    Seq Age Sex Outcome Treatment
    1