BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11642824 · Received April 9, 2021

    Report

    Report Number
    2031966-2021-00051
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 9, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517594204
    PMA / PMN Number
    K143684
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANTERIOR/POSTERIOR RADIOGRAPH WAS PROVIDED CONFIRMING SCREW AND ROD FRACTURE. THE PATIENTS POST OP ACTIVITY LEVELS COULD NOT BE CONFIRMED. FUSION OF BONE COULD NOT BE CONFIRMED. IT IS UNKNOWN WHETHER THE PATIENT HAD EXPERIENCED A FALL OR OTHER ACCIDENT. THE ROOT CAUSE COULD NOT BE DETERMINED AND NO ADDITIONAL INVESTIGATION COULD BE COMPLETED. THE PATIENT IS RECOVERING WELL POST REVISION. LABEL REVIEW "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS. AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES... POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE... BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)...NONUNION OR DELAYED UNION..." "...WARNINGS, CAUTIONS AND 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. METALLIC INTERNAL FIXATION DEVICES CANNOT WITHSTAND THE ACTIVITY LEVELS AND/OR LOADS EQUAL TO THOSE PLACED ON NORMAL, HEALTHY BONE. THESE DEVICES ARE NOT DESIGNED TO WITHSTAND THE UNSUPPORTED STRESS OF FULL WEIGHT OR LOAD BEARING ALONE..." "...THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOAD ASSOCIATED WITH DELAYED UNION OR NONUNION. INTERNAL FIXATION APPLIANCES ARE LOAD-SHARING DEVICES THAT HOLD BONY STRUCTURES IN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PATIENT¿S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT. ¿" "...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...."

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A SPINAL PROCEDURE TO ADDRESS KYPHOSIS FROM T10 TO S2A1 WITH A SPACER CAGE BEING PLACED BETWEEN L5/S. ON AN UNKNOWN DATE THE PATIENT HEARD A SOUND AND FOLLOWED UP ON (B)(6) 2021 WHERE RADIOGRAPHS CONFIRMED THAT THE LEFT ROD HAD FRACTURED AROUND L5/S1 AND A SCREW HEAD HAD FRACTURED AT S2A1. THE PATIENT UNDERWENT REOPERATION ON (B)(6) 2021 WHERE THE FRACTURED SCREW AND ROD WERE REPLACED AND AN EXTRA ROD WAS ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539577 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 15455500 N248171 00887517594204

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention