BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 13483320 · Received February 8, 2022

    Report

    Report Number
    2031966-2022-00033
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 8, 2022
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517534699
    PMA / PMN Number
    K143684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RECEIVED AS THE ORIGINAL CONSTRUCT REMAINS IN SITU AND NO PRODUCT FAULT WAS ALLEGED. NO RADIOGRAPHS COULD BE PROVIDED CONFIRMING THE ALLEGED COMPLAINT AND THE PATIENTS POST OP ACTIVITY LEVELS ARE UNKNOWN. THE ROOT CAUSE OF THE EVENT IS UNKNOWN BUT PROXIMAL JUNCTIONAL KYPHOSIS (PJK) IS A COMMON COMPLICATION FOLLOWING ADULT SPINAL DEFORMITY SURGERY OR A LONG SPINAL FUSION. NO ADDITIONAL INVESTIGATION REQUIRED. LABELING 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: DECREASE IN BONE DENSITY DUE TO STRESS SHIELDING PARALYSIS." "POST-OPERATIVE WARNINGS: DURING THE POSTOPERATIVE PHASE IT IS OF PARTICULAR IMPORTANCE THAT THE PHYSICIAN KEEPS THE PATIENT WELL INFORMED OF ALL PROCEDURES AND TREATMENTS. DAMAGE TO THE WEIGHT-BEARING STRUCTURES CAN GIVE RISE TO LOOSENING OF THE COMPONENTS, DISLOCATION AND MIGRATION, AS WELL AS TO OTHER COMPLICATIONS. TO ENSURE THE EARLIEST POSSIBLE DETECTION OF SUCH CATALYSTS OF DEVICE DYSFUNCTION, THE DEVICES MUST BE CHECKED PERIODICALLY POSTOPERATIVELY, USING APPROPRIATE RADIOGRAPHIC TECHNIQUES."

    Description of Event or Problem · 0

    ON A UNKNOWN DATE A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM T10-L5. POST OP THE PATIENT DEVELOPED PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND ON (B)(6) 2020 IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TO ADDRESS THE PJK BY EXTENDING THE CONSTRUCT FROM T10 TO T5. IT WAS REPORTED THE PATIENT WAS NOT EXPERIENCING ANY ADVERSE SYMPTOMS OTHER THAN THE PJK INDUCED PARALYSIS AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595324 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 10055440 NA 00887517534699

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention