BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM

    MDR report key: 11029637 · Received December 17, 2020

    Report

    Report Number
    1526439-2020-02428
    Event Type
    Injury
    Date Received
    December 17, 2020
    Date of Event
    November 23, 2020
    Report Date
    November 23, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265742
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE DISENGAGEMENT HAPPENED ON BOTH SIDES (LEFT AND RIGHT OF PATIENT CONSTRUCT) AND IN BOTH CASES ON AT LEAST TWO SCREWS. ON THE RIGHT SIDE THE TOWERS DISENGAGED FROM THE L3 SCREW AND THE L5 SCREW. ON THE LEFT SIDE THE TOWER CAME AWAY FROM THE SAI SCREW. THE ROD WAS UNABLE TO ENGAGE WITH THE L4 SCREW ON THE LEFT SIDE AND EVENTUALLY THIS WAS EXPLANTED TOWARDS THE END OF THE PROCEDURE AND THIS LEVEL WAS SKIPPED ON THE LEFT SIDE. THE ROD WAS JUST SITTING TOO FAR OFF THE HEAD OF THE SCREW TO BE ABLE TO GET THE REDUCTION INSTRUMENTS TO ENGAGE THERE THREADS AND I DON¿T THINK THAT THE SURGEON WANTED TO REMOVE THE ROD COMPLETELY TO RECONTOUR THE ROD SO THAT IT WOULD.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A SECOND STAGE POSTERIOR FIXATION ON A PREVIOUSLY FIXED L4/5/S1 ANTERIOR/LATERAL FIXATION WHERE THE PATIENTS L5 WAS SLIPPING, THE SURGEON WAS FUSING THE L4-S2AI POSTERIORLY TO REDUCE/FIXATE SLIP AND DECOMPRESS VIA A MINIMALLY INVASIVE SURGERY (MIS) APPROACH WITH CEMENT AUGMENTATION. THE APPROACH WAS TO USE VIPER 2 CFX SCREWS L4-S1 AND THEN VIPER SAI SCREWS INTO SACRAL ILIAC PERCUTANEOUSLY WITH THE AIM TO FURTHER ENHANCE THE FIXATION WITH CEMENT AUGMENTATION L4-S1. THE PEDICLES WERE SUCCESSFULLY TARGETED USING BRAINLAB NAVIGATION AND AUGMENTED SCREWS USING CONFIDENCE CEMENT UNDER FLUOROSCOPY. THE ROD WAS INSERTED VIA THE VIPER 2 EXTENSIONS SUCCESSFULLY. DURING THE REDUCTION OF THE ROD INTO THE HEADS OF THE SCREWS USING THE VIPER 3D REDUCTION INSTRUMENTS, THE TOWERS LOST GRIP ON THE TOP NOTCH OF THE VIPER 2 CFX SCREWS CAUSING THEM TO DISENGAGE ONCE REDUCTION FORCES WERE PUT ON THE TOWERS. THIS HAPPENED ON MULTIPLE OCCASIONS, AT LEAST FOUR (4) DIFFERENT SCREW EXTENSION TOWERS FAILED DURING PRIMARY ATTEMPTS AND AT LEAST FOUR (4) MORE FAILED IN SUBSEQUENT ATTEMPTS. SURGEON WAS FORCED TO CONVERT TO MINI OPEN INCISION WHICH INCREASED INCISION EXPOSURE, INCREASED BLOOD LOSS AND CAUSED LENGTHY DELAYS IN THE CASE LENGTH (INCREASE OF AT LEAST NINETY (90) MINUTES). THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A COMBINATION OF ADDITIONAL INSTRUMENTS INCLUDING RESORTING TO USING A COMPETITIVE PRODUCT (NUVASIVE). THE PATIENT IS RECOVERING FINE. CONCOMITANT DEVICE: UNKNOWN RODS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN ) THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1491182 VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 90MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704890 10705034265742

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention UNKNOWN RODS| UNKNOWN RODS