BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM X 25MM S-LOK POLYAXIAL SCREW

    MDR report key: 3490933 · Received November 12, 2013

    Report

    Report Number
    3005739886-2013-00042
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 14, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL WAS NOT POSSIBLE AS THE PRODUCT REMAINS IMPLANTED IN THE PT. REVIEW OF PHOTOGRAPHIC IMAGE PROVIDED OF THE CONSTRUCT IN VIVO, NOTED SPLAY ON THE LEFT SIDE OF ONE OF THE TULIP HEADS. ALTHOUGH, IT COULD NOT BE DEFINITIVELY CONFIRMED, CROSS THREADING OF THE CAP SCREW INTO THE TULIP HEAD CAN CAUSE SPLAYING AND ALSO CREATE DEBRIS AS NOTED IN THE DESCRIPTION OF THE EVENT. REVIEW OF MFG HISTORY AND LOT SPECIFIC COMPLAINT HISTORY WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. REVIEW OF COMPLAINT HISTORY FOR REPORTS OF THIS NATURE ON ALL PART NUMBERS IN THIS PRODUCT FAMILY DID NOT REVEAL A TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON (B)(6) 2013, AFTER PLACING THE SECOND ROD IN THE POSTERIOR CERVICAL SYSTEM, UPON APPLYING TORQUE TO THE T1 CAP SCREW THE SALES REP NOTED IT SOUNDED DIFFERENT THAN NORMAL. AFTER REMOVING THE ANTI-TORQUE SHAFT, BOTH THE REP AND THE SURGEON NOTICED THAT THE TULIP HEAD WAS SPLAYED. DEBRIS FROM THE SCREW HEAD WAS ALSO NOTED AND CLEANED FROM THE PT'S WOUND. THE SURGEON REMOVED THE CAP AND PLACED A NEW ONE BUT COULD NOT SUCCESSFULLY APPLY THE RECOMMENDED TORQUE. THE SCREW HAD PROPER ORIENTATION AND CONTACT WITH THE ROD AND THE SURGEON DECIDED NOT TO REMOVE THE SCREW. THERE WAS A DELAY TO THE PROCEDURE OF APPROXIMATELY FIVE (5) MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584262 4.5MM X 25MM S-LOK POLYAXIAL SCREW MNI SPINAL USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention