BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DTL SET SCREW

    MDR report key: 2810008 · Received October 23, 2012

    Report

    Report Number
    9613350-2012-00991
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT (SET SCREW) IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED WHEN THE DEVICE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SPINAL FUSION SURGERY, DIFFICULTY INSERTING THE SET SCREW OCCURRED. THE PATIENT WAS UNDERGOING A 1 LEVEL DTL PROCEDURE FOR GRADE 1 SPONDYLOLYSIS AT L4-L5 USING A MINIMALLY INVASIVE TECHNIQUE WITH A RETRACTOR. IT WAS REPORTED THAT THE PATIENT WAS AVERAGE WEIGHT AND OSTEOPOROTIC. THE RIGHT SIDE WAS COMPLETED FIRST. ON THE LEFT SIDE, THE MOST CAUDAL SCREW WAS PUT IN AND LOCKED DOWN. THEN THE 6.4X45MM CEPHALAD SCREW AT L4 WAS PUT IN. THE SURGEON ENCOUNTERED DIFFICULTY WITH THE ANGLE REQUIRED FOR THE MINIMALLY INVASIVE TECHNIQUE WHILE USING THE GLIDE INSERTER TO GET THE SET SCREW PUT IN. THE SURGEON ATTEMPTED TO INSERT THE SET SCREW BUT WAS UNABLE TO GET THE SET SCREW LOCKED DOWN ALL THE WAY. THE SCREW BONE INTERFACE BECAME LOOSE AND THE SCREW BEGAN TO TOGGLE. THAT SCREW HAD TO BE REMOVED AND REPLACED WITH A LARGER 7.2X50MM SCREW, WHERE THE SAME THING OCCURRED. SEVERAL DIFFERENT INSTRUMENTS WERE ATTEMPTED TO BE USED TO ASSIST AND AGAIN THE SCREW BEGAN TO TOGGLE AND WAS THEN PUSHED INTO THE BONE. THE SURGEON THEN HAD TO REMOVE THAT SCREW AND APPLY BONE CEMENT. AFTER THE BONE CEMENT WAS APPLIED, ANOTHER 7.2X50MM SCREW WAS IMPLANTED AND THE SET SCREW WAS SUCCESSFULLY INSERTED AND TIGHTENED. IN TOTAL, 6 SET SCREWS WERE ATTEMPTED AND STRIPPED AND THE TWO SCREWS ATTEMPTED WERE REPORTED TO BE "CHEWED UP." THE EVENT CONTRIBUTED TO A 3 HOUR DELAY DURING SURGERY. IT IS REPORTED THAT THE PATIENT DID FINE AFTER SURGERY AND WAS RELEASED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTL SET SCREW DTL SET SCREW NKB ZIMMER, INC. 0103810006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R