BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER MIS CANNULATED X-TAB 5X45MM TI

    MDR report key: 3961515 · Received July 28, 2014

    Report

    Report Number
    1526439-2014-11718
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATIONIF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE VIPER MIS CANNULATED X-TAB 5X45MM SCREW WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE CANNULATED X-TAB SCREW WAS CONDUCTED ON THE SPECIFIC CODE FROM THE COMPLAINT AS THE SHANK DIAMETER AND SCREW LENGTH HAVE A DIRECT RELATIONSHIP WITH THE SCREW¿S ABILITY TO WITHSTAND PULL OUT FORCES. THIS ANALYSIS FOUND NO RELATED COMPLAINTS. WITHOUT THE RETURN OF THE X-TABS SCREWS INVOLVED IN THIS CASE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE ACTION/PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO SYSTEMIC TREND HAS BEEN OBSERVED. THEREFORE, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE SAMPLES OF CONCERN FROM THIS COMPLAINT FILE BECOME AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INTRA-OPERATIVELY AFTER EXTREME LATERAL INTERBODY FUSION (XLIF), PERCUTANEOUS PEDICLE SCREW (PPS) POSTERIOR FIXATION WAS BEING PERFORMED USING VIPER CANNULATED X-TAB SCREWS. LEVELS L2 AND L3 WERE FIXED WITH 5MM X-TAB SCREWS WHILE L4 WAS FIXED WITH 6MM X-TAB IT WAS OBSERVED AT L3 THAT THE PERCUTANEOUS SCREW ON THE RIGHT SIDE WAS POSITIONED UPWARDS DUE TO CENTRUM ROTATION WHICH CREATED A GAP BETWEEN L3 AND L4 IN ROD REDUCTION. TO BALANCE THEM, ROD BENDING WAS DONE BUT THE SCREWS AT L3 AND L4 WERE FOUND TO BE LOOSENED AND COMING OFF FROM BONE. THE SCREWS WERE EASILY REMOVED BY HAND WITHOUT USE OF A DRIVER. THE SURGEON USED OTHER SCREWS TO COMPLETE THE CASE. THE RIGHT SIDE WAS FIXED THROUGH AN OPEN APPROACH. DUE TO THE NEED TO GO FROM A MINIMALLY INVASIVE/PERCUTANEOUS PROCEDURE TO AN OPEN PROCEDURE, THE OPERATION WAS EXTENDED FOR 60 MIN AND RESCHEDULING OF THE POSTOPERATIVE PLAN (EXTERNAL FIXATION AND REHABILITATION) BECAME NECESSARY. THE PATIENT IS NOW TREATED BY WEARING A CORSET. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO VIPER CANNULATED X-TAB SCREWS THAT PULLED OUT OF THE BONE, RESULTING IN THE NEED TO GO THE TO OPEN PROCEDURE: 1526439-2014-11717; 1526439-2014-11718.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437871 VIPER MIS CANNULATED X-TAB 5X45MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ARBD87

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention