BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTIMA

    MDR report key: 2896645 · Received December 26, 2012

    Report

    Report Number
    9617297-2012-00003
    Event Type
    Other
    Date Received
    December 26, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 12, 2012
    Manufacturer
    U&I CORPORATION
    Product Code
    KWQ
    PMA / PMN Number
    K020279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON DIDN'T USE THE RELEVANT INSTRUMENTS (ROD PUSHER, ETC.) FOR SECURING THE SET SCREW IN THE OPERATION. IN OUR OPINION, THE SURGEON SHOULD HAVE FOLLOWED THE SURGICAL TECHNIQUES DURING OPERATION, BUT HE IGNORED THE IFU AND SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    THE SURGEON PLACED A 6X40MM POLYAXIAL SCREW ON THE LEFT SIDE OF THE SACRAL ON VERTEBRAE (S1). THEN AFTER PLACING A ROD, THE SURGEON WAS TRYING TO PLACE THE SET SCREW. WHEN TRYING TO TIGHTEN WITH TORQUE DRIVER SURGEON NOTICE METAL SHAVINGS COMING FROM THE SET SCREW. HE REMOVED THE SET SCREW AT THIS TIME AND THEN ATTEMPTED TO PLACE TWO OTHER SET SCREWS W/O SUCCESS. THE SURGEON THEN REMOVED THE ROD AND THE 6X40MM POLYAXIAL SCREW FROM LEFT SIDE OF S1 AND REPLACED THEN WITH A 7X40MM POLYAXIAL SCREW AND ROD. A NEW SET SCREW WAS PLACED W/O DIFFICULTY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE). SEE SCANNED PAGE. ADD'L INFO REC'D BY DISTRIBUTOR ON (B)(6) 2012: THE MAIN ISSUE WAS THAT THE ROD WAS NOT FULLY SEATED IN THE SCREW HEADS. SURGEON WAS USING A CURVED 6.0X70MM (HE IS PRETTY SURE THIS WAS THE SIZE, BUT NOT 100%) ROD. CONFIRMED THAT THIS WAS OCCURRED IN THE SACRUM, LEFT SIDE, AND WAS THE LAST SET SCREW TO BE ADDRESSED. WAS USING THE AXIAL TORQUE WRENCH AND STANDARD COUNTER TORQUE. AS THE SET SCREWS CROSS THREADED, SHAVINGS FELL INTO THE WOUND BUT WERE ALL SUBSEQUENTLY RETRIEVED. THE SCREW WAS REMOVED AND REPLACED WITH THE LARGER SCREW, AND INITIALLY, AGAIN, THE ROD WAS NOT FULLY SEATED. THE SURGEON DOES NOT USUALLY LIKE TO USE THE INSTRUMENTS TO MANIPULATE THE SCREWS DURING USE. HOWEVER WITH THE SECOND ATTEMPT, UPON URGING FROM THE REP, THE SURGEON DID PULL ANOTHER INSTRUMENT TO ASSIST WITH THE ROD PLACEMENT. REP CANNOT RECALL EXACTLY WHAT INSTRUMENT WAS USED FROM THE OPTIMA SET BUT THE FINAL SET SCREW WAS THEN ABLE TO BE PLACED. THIS WAS A 2 LEVEL CASE, S1, L5, L4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA ORTHOSIS, SPINAL PEDICLE FIXATION KWQ U&I CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other