BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11692979 · Received April 20, 2021

    Report

    Report Number
    2031966-2021-00055
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 20, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517551702
    PMA / PMN Number
    K182974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5 WAS CHANGED TO CORRECT DATE.

    Description of Event or Problem · 0

    ON (B)(6) 2020, A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L2/L4. ON AN UNKNOWN DATE DURING A FOLLOW-UP AN X-RAY REVEALED THAT A LOCK SCREW CAME OFF AT RIGHT L4. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY PAIN AND HAD NORMAL PHYSICAL ACTIVITY. ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO REPLACE THE LOCK SCREW AND INTEROPERATIVELY THE PHYSICIAN NOTICED THAT THE LEFT L4 LOCK SCREW WAS ALSO LOOSE AND REPLACED THAT LOCK SCREW AS WELL. BONE FUSION WAS OBSERVED AT L2/3, BUT NOT AT L3/4.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION. RADIOGRAPHS PROVIDED CONFIRM THE ALLEGED MALFUNCTION. THE PATIENT'S POST-OPERATIVE ACTIVITY IS UNKNOWN. THE ROOT CAUSE CANNOT BE DETERMINED HOWEVER REVIEW OF THE REPORTED INFORMATION SUGGESTS INSUFFICIENT TORQUE OR ROD INTERFERENCE AS POSSIBLE CAUSE OR CONTRIBUTORS AND 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 COMPONENT(S), LOSS OF FIXATION..." "...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. ALL LOCK SCREWS SHOULD BE FINAL-TIGHTENED WITH THE COUNTER-TORQUE AND TORQUE T-HANDLE. CARE SHOULD BE TAKEN TO INSURE THAT ALL COMPONENTS ARE IDEALLY FIXATED PRIOR TO CLOSURE..." "...PATIENT EDUCATION: 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 DEVICE(S) 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 PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L2/L4. ON AN UNKNOWN DATE DURING A FOLLOW-UP AN X-RAY REVEALED THAT A LOCK SCREW CAME OFF AT RIGHT L4. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY PAIN AND HAD NORMAL PHYSICAL ACTIVITY. ON (B)(6) 2021 A REVISION SURGERY WAS PERFORMED TO REPLACE THE LOCK SCREW AND INTEROPERATIVELY THE PHYSICIAN NOTICED THAT THE LEFT L4 LOCK SCREW WAS ALSO LOOSE AND REPLACED THAT LOCK SCREW AS WELL. BONE FUSION WAS OBSERVED AT L2/3, BUT NOT AT L3/4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591558 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 13550000 N263698 00887517551702

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR