BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPUBLIC SPINE DARK STAR PEDICLE SPINAL SYSTEM

    MDR report key: 12969901 · Received December 9, 2021

    Report

    Report Number
    3011796723-2021-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 9, 2021
    Manufacturer
    REPUBLIC SPINE, LLC
    Product Code
    NKB
    PMA / PMN Number
    K150283
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DIFFICULT EVENT TO ACCESS ACCURATELY, SO THE AUTHOR WILL PROVIDE BEST EFFORT ON THIS ANALYSIS. THE SURGEON WAS EXPLICIT THAT THE RATIONAL FOR REVISION SURGERY WAS DUE TO THE INTERBODY CAGE MIGRATION AND NOT THE PEDICLE SCREW SYSTEM. THERE WAS NO EVIDENCE OF FAILURE IN THE PREVIOUS SURGERY OR IN THE FOLLOW UP DISCOVERY, BUT FAILURE OCCURRED IN A REVISION SURGERY. IN ADDITION, THE HOSPITAL DISCARDED THE IMPLANT, SO EX POST FACTO ANALYSIS IS IMPOSSIBLE. THE REPRESENTATIVE INDICATED THAT THE SURGEON DECIDED TO REMOVE THE IMPLANTS AND USE A SEPARATE COMPANY BECAUSE THE SURGEON WAS MORE COMFORTABLE PERFORMING A REVISION WITH A COMPETITOR'S INSTRUMENTATION (THIS WAS DECIDED PRIOR TO THE START OF THE SURGERY). THE FOLLOWING ANALYSIS INCLUDES CONJECTURE DERIVED FROM INCOMPLETE DATA. THIS SECTION IS INCLUDED TO SHOW THAT THE MANUFACTURE IS MAKING BEST EFFORT TO ENSURE THAT THIS DEVICE IS NOT PRESENTING A HAZARD TO PATIENTS. THE TIME BETWEEN THE INITIAL SURGERY AND THE REVISION IS APPROXIMATELY 14 MONTHS. BONE FUSION RESULTS ARE TYPICALLY EXPECTED TO OCCUR IN SIX MONTHS. THE MANUFACTURE ATTRIBUTES THE FAILURE AT REVISION TO THE ADDITIONAL CYCLE LOADS STEMMING FROM NONUNION, WHICH WOULD WEAKEN THE DEVICE AT EITHER THE ROD OR NECK OF THE SCREW. THIS IS NOT UNCOMMON FOR PEDICLE SCREW DEVICES TO FAIL AFTER AN ADDITIONAL EIGHT MONTHS OF CYCLIC LOAD. THE SURGEON STATED THAT HE WAS ABLE TO LOAD THE DRIVER INTO THE SCREW WHICH INDICATES THAT THE SCREW WAS INTACT PRIOR TO ATTEMPTING REMOVAL. HOWEVER, IT IS POSSIBLE THAT BONE BEGAN TO GROW AROUND THE NECK OF THE SCREW AND WOULD MAKE THE SCREW DIFFICULT TO REMOVE. THIS WOULD IN TURN INCREASE THE REQUIRED REMOVAL TORQUE AND WITH EXCESS CYCLIC LOADING COULD LEAD TO THIS FAILURE OCCURRING AGAIN. THE RISKS OF PROLONGED CYCLES DUE TO NONUNION ARE INCLUDED IN THE FMEA OF THIS PRODUCT AND WILL BE REVIEWED TO DETERMINE IF THE PROBABILITY SHOULD BE UPDATED. CURRENTLY THE RISK ASSOCIATED WITH THIS FAILURE, WHILE UNFORTUNATE, IS TOLERABLE.

    Description of Event or Problem · 0

    THIS EVENT IS RELATED TO A REVISION SURGERY, SO THE AUTHOR HAS DECIDED TO PROVIDE BACKGROUND OF THE PREVIOUS SURGERY AS PART OF THE EVENTS DESCRIPTION. BACKGROUND: ON (B)(6) 2020 THE SURGEON IMPLANTED TWO PEDICLE SCREWS FROM THE MANUFACTURE IN EACH VERTEBRAL LEVEL FROM L4 TO S1 (SIX TOTAL), AN EXPANDABLE INTERBODY CAGE (DIFFERENT MANUFACTURE) AT L5-S1, AND A STATIC TLIF AT L4-L5 (SEPARATE MANUFACTURE). SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITHOUT ANY COMPLAINTS OR FEEDBACK. FOLLOW UP DISCOVERY: AT AN UNKNOWN DATE PRIOR TO THE EVENT. THE SURGEON PERFORMED FOLLOW UP IMAGING OF THE PATIENT AND DISCOVERED THAT THE EXPANDABLE INTERBODY CAGE (PROVIDED BY A SEPARATE AND DIFFERENT MANUFACTURE) HAD MIGRATED TO AN UNACCEPTABLE LOCATION. REVISION SURGERY AND CAUSE OF THE ADVERSE EVENT. THE SURGEON PERFORMED THE REVISION SURGERY FROM AN OPEN POSTERIOR APPROACH OF THE LOWER LUMBER SPINE ON (B)(6) 2021. THE SURGEON WAS ABLE TO REMOVE THE INTERBODY CAGES AND FIVE OF THE PEDICLE SCREWS. WHEN REMOVING THE PEDICLE SCREW LOCATED IN THE RIGHT SIDE OF S1 VERTEBRAL BODY, THE SURGEON DISCOVERED THAT THE SCREW HEAD HAD DETACHED FROM THE SCREW BODY. THE REPRESENTATIVE DID NOT RECEIVE FEEDBACK ABOUT THE ORIGIN OR REASON OF THE EVENT. THE SURGEON ATTEMPTED TO REMOVE THE REMANENT OF THE SCREW, BUT WAS UNSUCCESSFUL AND WAS UNABLE TO EXPLANT THE SCREW. THE SURGEON IMPLANTED NEW SCREWS ON THE OTHER LEVELS FROM L3-S2 (SKIPPING S1) WITH IMPLANTS FROM A DIFFERENT PEDICLE SCREW MANUFACTURE. NO INFORMATION WAS REQUESTED ABOUT THE EXPANDABLE INTERBODY CAGES FROM A SEPARATE MANUFACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1867964 REPUBLIC SPINE DARK STAR PEDICLE SPINAL SYSTEM DARK STAR NKB REPUBLIC SPINE, LLC 100220-C-7535 25901

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ASSOCIATED RODS AND LOCKING SCREWS