BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5 MM X 45 MM S-LOK POLYAXIAL SCREW

    MDR report key: 3208906 · Received July 2, 2013

    Report

    Report Number
    3005739886-2013-00018
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SPINAL USA, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE TWO SCREWS INVOLVED IN THE REPORTED EVENT ARE FROM THE SAME LOT, ONLY ONE MEDWATCH REPORT IS BEING FILED. EVALUATION OF THE RETURNED SCREWS FOUND BOTH TO BE WITHIN DESIGN SPECIFICATION WITH THE EXCEPTION OF THE HEX IN THE SCREW HEADS, WHICH WERE DAMAGED FROM INSERTION ATTEMPTS AND COULD NOT BE ACCURATELY MEASURED. BENCH TESTING WAS PERFORMED IN EFFORT TO REPLICATE THE FAILURE MODE ENCOUNTERED. POTENTIAL ROOT CAUSES IDENTIFIED ARE AS FOLLOWS: THE USE OF THE INCORRECT TAP FOR PEDICLE PREPARATION. LESS THAN OPTIMAL SCREWDRIVER AND SCREW HEAD ENGAGEMENT DURING INSERTION. AS A RESULT, THE FOLLOWING CORRECTIVE ACTIONS WILL BE IMPLEMENTED: OPTIMIZATION OF SCREWDRIVER AND SCREW HEAD INTERFACE. INCREASED O.R. STAFF TRAINING ON THE UTILIZATION OF THE CORRECT TAPS FOR THIS PROCEDURE. REVIEW OF RECEIVING INSPECTION REPORTS FOR P/N SLC6545 LOT 4158TS FOUND A TOTAL OF FORTY (40) UNITS OF THIS LOT WERE RECEIVED IN (B)(4)L OF 2012 AND RELEASED FOR DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF COMPLAINT HISTORY FOUND THIS TO BE THE FIRST REPORT OF THIS NATURE RECEIVED FOR ANY PART NUMBER IN THIS PRODUCT FAMILY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2013, THE L4 PEDICLE WAS OPENED WITH A 3.2 MM DRILL AND SUBSEQUENTLY TAPPED WITH A 5.5 MM TAP. A 6.5 MM X 45 MM SLC SCREW WAS PLACED IN THE PEDICLE BUT WOULD ONLY SEAT ONE THIRD OF THE WAY. THE SCREW WAS REMOVED AND THE PEDICLE WAS TAPPED WITH A 6.5 MM TAP, THE SCREW WAS THEN PLACED AGAIN BUT STILL WOULD NOT SEAT FULLY. THE SCREW WAS REMOVED AND A SECOND 6.5 MM X 45 MM SLC SCREW WAS ATTEMPTED, WHICH ALSO WOULD NOT FULLY SEAT. A THIRD 6.5 MM X 45 MM SLC SCREW WAS ATTEMPTED AND WAS FULLY PLACED IN THE PEDICLE. THE L5 PEDICLE WAS THEN DRILLED WITH A 3.2 MM DRILL AND WHEN ATTEMPTING TO TAP WITH THE PSSCT65 TAP, THE TAP WOULD NOT PENETRATE THE PEDICLE WALL. SUBSEQUENTLY THE DOCTOR DECIDED TO REMOVE THE SCREW PLACED IN THE L4 PEDICLE AND COMPLETE THE PROCEDURE UTILIZING A COMPETITOR'S PRODUCT. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 20 MINUTES DUE TO THE REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301054 6.5 MM X 45 MM S-LOK POLYAXIAL SCREW 6.5 MM X 45 MM S-LOK POLYAXIAL SCREW MNI SPINAL USA, INC. 4158TS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention