BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11930036 · Received June 3, 2021

    Report

    Report Number
    2031966-2021-00076
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 3, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517554734
    PMA / PMN Number
    K182974
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AS THE DEVICE IS STILL IN-SITU. RADIOGRAPHS PROVIDED CONFIRM THE DEVICE MALFUNCTION. FUSION WAS COMPLETE. IT IS UNKNOWN IF THE PATIENT EXPERIENCED A FALL. REVIEW OF THE PROVIDED INFORMATION WAS INCONCLUSIVE AND THE ROOT CAUSE CANNOT BE DETERMINED. POSSIBLY RELATED TO EXCESSIVE LOADING OR POST-OPERATIVE PHYSICAL ACTIVITY. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABELING REVIEW: "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS: AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENTS..." "...WARNINGS, CAUTIONS, PRECAUTIONS: CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. THE POTENTIAL FOR SUCCESS IS INCREASED BY THE SELECTION OF THE PROPER SIZE OF THE IMPLANT. WHILE PROPER SELECTION CAN MINIMIZE RISKS, THE SIZE AND SHAPE OF HUMAN BONES PRESENT LIMITATIONS ON THE SIZE AND STRENGTH OF IMPLANTS. CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE..." "...PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS. THE PATIENT MUST BE MADE AWARE THAT IMPLANT COMPONENTS MAY BEND, BREAK OR LOOSEN EVEN THOUGH RESTRICTIONS IN ACTIVITY ARE FOLLOWED..." "...PRE-OPERATIVE WARNINGS: CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICES AND INJURY TO THE PATIENT..." "...POST-OPERATIVE WARNINGS: DAMAGE TO THE WEIGHT-BEARING STRUCTURES CAN GIVE RISE TO LOOSENING OF THE COMPONENTS, DISLOCATION AND MIGRATION, AS WELL AS TO OTHER COMPLICATIONS..."

    Description of Event or Problem · 1

    ON (B)(6) 2020 A POSTERIOR LUMBAR INTERBODY FUSION AT T10/S2AI. ON (B)(6) 2021 A REVISION SURGERY OCCURRED DUE TO A ROD FRACTURE AT LEFT L5/S1 AND A SCREW FRACTURE AT RIGHT S2AI. (2031966-2021-00051) ON (B)(6) 2021 DURING A ROUTINE FOLLOW-UP AN X-RAY REVEALED THAT THE RIGHT S2AI SCREW FRACTURED. BONE FUSION WAS REPORTEDLY COMPLETE AND THE PATIENT'S PHYSICAL ACTIVITY LEVEL WAS NORMAL. THE PHYSICIAN STATED THEY WILL CONTINUE TO MONITOR THE PATIENT. NO REVISION SURGERY PLANNED AND NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824750 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 16019580 SA3080 00887517554734

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR