BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM X 50MM S-LOK POLYAXIAL SCREW

    MDR report key: 3208913 · Received July 2, 2013

    Report

    Report Number
    3005739886-2013-00020
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    June 6, 2013
    Manufacturer
    SPINAL USA, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED INDICATES THAT THE PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. TO DATE PRODUCT HAS NOT BEEN RECEIVED. SHOULD THE PRODUCT BE RECEIVED, A FOLLOW-UP MEDWATCH REPORT WILL BE FILED AFTER COMPLETION OF EVALUATION. REVIEW OF RECEIVING INSPECTION REPORT FOUND THAT A TOTAL OF THREE HUNDRED AND ONE (301) UNITS OF THIS LOT WERE RECEIVED FROM THE SUPPLIER AND RELEASED FOR DISTRIBUTION IN (B)(4) 2011, WITH NO DEVIATION OR ANOMALIES. REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ANY ADDITIONAL ISSUES OF THIS NATURE REPORTED FOR THIS LOT. REVIEW OF COMPLAINT HISTORY FOR ALL PART NUMBERS IN THIS PRODUCT FAMILY DID NOT IDENTIFY A TREND FOR ISSUES OF THIS NATURE. ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THIS REPORT IS 2 OF 2 MDRS FILED FOR THE SAME EVENT (REF. 3005739886-2013-00019 AND 00020).

    Description of Event or Problem · 1

    DURING A PROCEDURE PERFORMED ON (B)(6) 2013, TWO SLP SCREWS WERE IMPLANTED USING THE TRANSPEDICULAR TECHNIQUE. AFTER THE ROD WAS PLACED, A CAP SCREW WAS USED TO SECURE THE BAR IN PLACE. WHEN TORQUE WAS APPLIED, THE SURGEON FELT THAT TOO MUCH STRENGTH WAS USED TO APPLY TORQUE, WHEN THE ANTI-TORQUE SLEEVE WAS REMOVED IT BECAME VISIBLE THAT THE TULIP HEAD PORTION OF THE SCREW HAD SPLAYED. BOTH SCREWS WERE REMOVED AND REPLACED WITH NO FURTHER ISSUE AND NO SIGNIFICANT DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301964 6.5MM X 50MM S-LOK POLYAXIAL SCREW PEDICLE SCREW SPINAL SYSTEM MNI SPINAL USA, INC. 3415TS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention