BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDN

    MDR report key: 19651534 · Received July 1, 2024

    Report

    Report Number
    8030965-2024-08168
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 4, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H6: 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.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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

    THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SECOND SURGERY PERFORMED 1 YEAR AFTER THE INITIAL SURGERY. THIS PC REPORTS THE CEMENT LEAKAGE AND DIFFICULTY IN THE FINAL FASTENING HAPPENED IN THE SECOND SURGERY. IT WAS REPORTED THAT THIS WAS A POSTERIOR LUMBAR INTERBODY FUSION (L3-4) PERFORMED WITH VIPER PRIME SCREWS ON AN UNKNOWN DATE ABOUT 1 YEAR AGO FROM (B)(6) 2024. AFTER THE SURGERY, ON (B)(6) 2024, THE SECOND SURGERY WAS PERFORMED TO ADD XLIF TO L2-3 AND L4-5, AND TO REMOVE L3-4 SCREWS AND FIX L2-5. THE CAUSE OF THE SECOND SURGERY IS UNKNOWN. IN THE SURGERY, VIPER PRIME FENESTRATED SCREWS WERE INSERTED IN L2-5. THE CEMENT WAS INJECTED INTO L2, L4, AND L5 (NO CONCERNS ABOUT THE ANCHORAGE OF L3). THE INJECTION BEGAN ABOUT 11 MINUTES AFTER CEMENT MIXING. VISCOSITY WAS ADEQUATE. CEMENT WAS INJECTED IN THE ORDER OF L4, L5, AND L2. THE LATERAL XRAY DID NOT CLEARLY SHOW CEMENTATION AT THE TIME OF L4 INJECTION. AT THE SURGEON'S DISCRETION, 1.5 ML WAS INJECTED BILATERALLY. DURING L5 INJECTION, THE STATE OF THE CEMENT COULD BE SEEN THROUGH XRAY. ONE ML WAS INJECTED ON EACH SIDE. IN L2, CEMENT WAS INJECTED 0.4 ML ON THE LEFT SIDE AND 0.8 ML ON THE RIGHT SIDE AS SOME EFFICACY WAS FELT ON THE SCREW. AFTER CEMENTING, CEMENT COULD NOT BE SEEN IN THE VERTEBRAL BODY OF L4 WHEN CHECKED IN THE FRONTAL XRAY; L2 AND L5 WERE FOUND TO BE ADEQUATE. WHEN L4 WAS CHECKED CAREFULLY FROM THE FRONT, A BLACK SHADOW NEAR THE SCREW HEAD WAS CONFIRMED. THE CEMENT WAS NOT PRESENT IN THE VERTEBRAL BODY, CONFIRMING LEAKAGE NEAR THE SCREW HEAD. THE CEMENT WAS ALSO VISUALLY OBSERVED TO BE LEAKING NEAR THE SCREW HEAD FROM THE L4 SCREW ENTRY POINTS ON BOTH SIDES. THE CEMENT IN QUESTION WAS REMOVED WITH A MEDULLARY FORCEPS. MEASURES WERE TAKEN TO PREVENT CEMENT FROM HARDENING IN THE THREADS BY PLACING A SET SCREW ONCE BEFORE ROD INSERTION. THE RODS AND SET SCREWS WERE INSTALLED ON BOTH SIDES TO APPLY COMPRESSION TO THE REQUIRED AREAS. THE SURGEON FELT DISCOMFORT DURING FINAL L4 FASTENING ON THE RIGHT SIDE. IT WAS DETERMINED THAT THE SET SCREW WAS NOT PROPERLY INSTALLED. THE SET SCREW AND ROD WERE REMOVED. THERE WAS A POSSIBILITY OF HARDENED CEMENT REMAINING IN THE L4 SCREW HEAD ON THE RIGHT SIDE, AND AN ATTEMPT WAS MADE TO REMOVE THE SCREW. THE HARDENED CEMENT REMAINED ON THE CORE OF THE SCREW AS WELL, PREVENTING THE SCREWDRIVER FROM CONNECTING. THE CEMENT REMAINING IN THE CORE WAS REMOVED USING AN ALIGNMENT DEVICE CLEANING STYLET AND HOSPITAL INSTRUMENTS, BUT COULD NOT BE COMPLETELY REMOVED. THE SCREW WAS SLOWLY ROTATED WHILE PRESSING THE SCREWDRIVER AGAINST IT, AND THE SCREW WAS REMOVED. A 5 MM LONGER SCREW WAS INSERTED WITH ROOM IN THE VERTEBRAL BODY. RODS AND SET SCREWS WERE PLACED AND FINAL FASTENING WAS PERFORMED. SUBSEQUENTLY, THE FINAL FASTENING OF THE OPPOSITE (LEFT) SIDE L4 WAS ALSO FOUND TO BE DIFFICULT, AND THE SCREW WAS EXTRACTED IN THE SAME MANNER AS THE RIGHT SIDE. THE CEMENT REMAINED IN THE SCREW CORE, MAKING EXTRACTION DIFFICULT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 40 MINUTES SURGICAL DELAY. THE SURGEON FELT SOME UNUSUAL DISCOMFORT AT THE TIME OF L4 CEMENT INJECTION, BUT HE DIDN'T PAY MUCH ATTENTION TO IT AT THE TIME, WHEN HE CHECKED THE SCREW THAT WAS REMOVED, THERE WAS EVIDENCE OF CEMENT COMING OUT OF THE TRANSVERSE HOLE. HE DOES NOT BELIEVE THERE WERE ANY PROBLEMS WITH THE HANDLING OF THE DEVICE (WITH RESPECT TO THE PLACEMENT OF THE ALIGNMENT DEVICE MENTIONED ABOVE, ETC.). HE IDENTIFIED CEMENT IN THE SCREW HEAD, HE ANTICIPATED SOME OF THE SUBSEQUENT DIFFICULTIES. IN PARTICULAR, THE MOST DIFFICULT PART WAS EXTRACTING THE SCREW, WHICH LEFT BEHIND HARDENED CEMENT. BEFORE THE ABOVE EVENT HAPPENED, WHEN ALIGNMENT DEVICES WERE PLACED ON THE SIX SCREWS SCHEDULED FOR CEMENT INJECTION TO CHECK THE CONNECTION WITH THE OPEN CANNULA, INITIALLY ALIGNMENT DEVICES FAILED TO CONNECT WITH THE OPEN CANNULA. AFTER SOME MINOR ADJUSTMENTS TO THE ORIENTATION OF THE ALIGNMENT DEVICES, IT WAS FINALLY CONFIRMED THAT THE OPEN CANNULAS WERE PROPERLY CONNECTED TO ALL ALIGNMENT DEVICES. IT WAS CONFIRMED BY THE SALES REP IN POSTOPERATIVELY THAT AN OPEN CANNULA COULD BE CONNECTED EVEN IF THE ALIGNMENT DEVICE WAS NOT PROPERLY PLACED ON THE SCREW. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. REMARKS: (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES SPINE): CEMENT. (B)(4) (DEPUY SPINE): SCREWS AND DEVICES. THIS REPORT IS FOR ONE (1) UNK - BIOMATERIAL - CEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564695 NDN ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown