BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM X 45MM S-LOK CANN POLY SCREW

    MDR report key: 3367207 · Received September 12, 2013

    Report

    Report Number
    3005739886-2013-00028
    Event Type
    Injury
    Date Received
    September 12, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 13, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVAL OF THE SCREW COMPONENTS FOUND ALL DIMENSIONS TO BE WITHIN DESIGN SPECIFICATIONS. VISUAL EVAL DID NOT IDENTIFY AND SIGNIFICANT DAMAGE TO THE MATING FACES OF THE COMPONENTS. INDENTS, MARKINGS, AND SKIVING WERE NOTED ON THE FACE OF THE TULIP TANGS. BASED ON THE EVAL RESULTS AND OBSERVATIONS OF THE ENGINEER PRESENT DURING THE PROCEDURE, IT APPEARS THAT THE ROD SAT ON TOP OF THE TULIP DURING ATTEMPTED INSERTION. WHEN THE DOCTOR IMPACTED THE ROD HOLDER, THE FORCE WAS TRANSMITTED TO THE TULIP, DRIVING IT DOWN WITH RESPECT TO THE SADDLE AND THE SHANK OF THE SCREW. THIS FORCE COULD CAUSE THE OBSERVED DAMAGE TO THE TULIP AS WELL AS THE DISASSEMBLY. REVIEW OF THE RECEIVING INSPECTION REPORT FOUND A TOTAL OF (B)(4) UNITS OF THIS LOT WERE RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION IN (B)(4) 2012, WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ANY ADDITIONAL ISSUES OF THIS NATURE REPORTED FOR THIS LOT, NOR WAS THERE A TREND IDENTIFIED FOR ISSUES OF THIS NATURE FOR THE PRODUCT FAMILY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ONE LEVEL L4-5 FUSION PERFORMED ON (B)(6) 2013, AN S-LOK ROD WAS BEING PLACED BETWEEN TWO SCREWS, USING THE MINI-MAX ROD EXCHANGE DILATORS. THE ROD WOULD NOT ADVANCE INTO THE HEAD OF THE TULIP AS THE TULIP ROTATED WITH RESPECT TO THE DILATOR, SUCH THAT THE ROD WAS SITTING CROSS-WISE ACROSS THE TULIP OPENING. THE DOCTOR TAPPED THE ROD HOLDER WITH A MALLET IN AN EFFORT TO GET THE ROD SEATED. ON FLUOROSCOPY, IT WAS NOTED THAT THE TULIP HEAD APPEARED TO BEND INWARD AT THIS POINT. THE DOCTOR PROCEEDED TO REMOVE THE SCREW, WITH THE TULIP SHANK AND A SADDLE PIECE COMING OUT, BUT AS SEPARATE COMPONENTS. THE FLUOROSCOPY THEN SHOWED THE LOCATION OF THE OTHER SADDLE PIECE, WHICH WAS EASILY REMOVED. THE SCREW WAS REPLACED WITH ANOTHER S-LOK SCREW THAT WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459904 6.5MM X 45MM S-LOK CANN POLY SCREW PEDICLE SCREW, SPINAL SCREW MNI SPINAL USA, INC 4357TS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R