BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STALIF L ABO SCREW

    MDR report key: 12057643 · Received June 24, 2021

    Report

    Report Number
    3007494564-2021-00058
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 22, 2021
    Manufacturer
    CENTINEL SPINE, LLC.
    Product Code
    OVD
    PMA / PMN Number
    K130461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY THE SURGEON INDICATES THE PATIENT WAS SUFFERING FROM SEVERAL COMPLICATIONS RELATED TO THE SUBSIDENCE OF THE STALIF L IMPLANT. THERE WAS NO CLEAR INDICATION THE DEVICE DID NOT CONTRIBUTE TO THIS CONDITION, THUS AN MDR IS REQUIRED FOR THIS EVENT. DHR REVIEW COULD NOT BE COMPLETED AS PART AND LOT NUMBERS WERE NOT PROVIDED. COMPLAINT TRENDING FOUND THIS TO BE THE FIRST COMPLAINT OF SUBSIDENCE AND PSEUDOARTHROSIS. THE RISK ASSESSMENT FOUND THAT SUBSIDENCE AND PSEUDOARTHROSIS ARE IDENTIFIED AS POSSIBLE HAZARDS AND HARMS WHICH CAN RESULT IN ADDITIONAL SURGEON AND OTHER COMPLICATIONS. THE RATE OF COMPLAINTS WAS FOUND TO BE ACCEPTABLE BASED ON THIS ASSESSMENT. NO DEVICES WERE RETURNED FOR ANALYSIS. REVIEW OF THE STALIF L IFU AND SURGICAL TECHNIQUE GUIDE NOTED THAT STALIF L IS REQUIRED TO HAVE SUPPLEMENTAL FIXATION. THE X-RAY IMAGES PROVIDED SHOW SUPPLEMENTAL POSTERIOR FIXATION WAS IN PLACE, BUT DID NOT SPAN ACROSS THE STALIF L L3/4 DISC SPACE. THE L3 VERTEBRAE WHICH SHOWS THE MOST SUBSIDENCE WAS NOT SUPPORTED WITH POSTERIOR FIXATION. THE SURGICAL TECHNIQUE GUIDE FOR STALIF L PROVIDES A SPECIFIC EXAMPLE SHOWING POSTERIOR FIXATION ACROSS BOTH PICTURED STALIF L LEVELS. ADDITIONALLY THERE HAS BEEN STUDIES WHICH SUGGEST THAT SMOKING CAN INCREASE THE RISK OF PSEUDOARTHROSIS. THE AMOUNT OF SMOKING PER DAY PROVIDED BY THE SURGEON SUGGESTS THIS MAY HAVE BEEN ANOTHER FACTOR IN THE PATIENT'S PSEUDOARTHROSIS. THE INVESTIGATION DID NOT FIND A SPECIFIC DEVICE PROBLEM. THE COMPLAINT IS LIKELY A PATIENT SPECIFIC CONDITION AND PATIENT-DEVICE INTERACTION PROBLEM WHICH MAY HAVE BEEN EXACERBATED BY OFF-LABEL USE AND PATIENT COMORBIDITY (FREQUENT SMOKING). THIS SUBMISSION IS FOR 1 OF 3 STALIF L DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT IS A FEMALE, BORN (B)(6), NO OSTEOPOROSIS, SMOKER (30-40 CIGARETTES/DAY), NO OTHER COMORBIDITIES WHO RECEIVED A STALIF-L IN L3/4 ABOUT 1.5 YRS AGO. PATIENT WAS ORIGINALLY IMPLANTED (B)(6) 2019. SURGEON WILL REMOVE THE STALIF-L IN L3/4 ON FRIDAY AND SHE WILL RECEIVE A VENTRAL RE-FUSION WITH A VENTRAL CAGE OF ANOTHER COMPANY (JNJ). ADDITIONAL INFORMATION PROVIDED INDICATES THE PATIENT HAS RADICULAR PAIN AT L3/4, SENSORY LOSS IN LEFT LOWER LEG, MILD PARESIS MEDIAL QUADRICEPS RELATED TO FORAMINAL STENOSIS L3/4. THE SURGEON CONFIRMED NO BONY FUSION WAS ACHIEVED, EROSION OF ENDPLATES AND MIGRATION (SUBSIDENCE) OF THE CAGE INTO VERTEBRAL BODIES L3/4, LOOSE SCREWS, REDUCTION OF HEIGHT RESULTING IN FORAMINAL STENOSIS AS A RESULT. THE PATIENT RECEIVED A DECOMPRESSION ON (B)(6) 2021 IN L3/4 AN DORSAL NEW-OSTEOSYNTHESIS L3-S1 (THE PREVIOUSLY USED OSTEOSYTHESIS-MATERIAL IS NO LONGER AVAILABLE, CLICKX/SYNTHES). STALIF L REMOVAL WAS COMPLETED ON (B)(6) 2021, AND REPLACED WITH EIT CONDUIT CAGE (DEPUY SYNTHES). THE STALIF L PEEK CAGE HAD TO BE CHISELED OUT OF THE DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959390 STALIF L ABO SCREW INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD CENTINEL SPINE, LLC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R