BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 11773336 · Received May 4, 2021

    Report

    Report Number
    2031966-2021-00064
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 16, 2021
    Report Date
    May 4, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517556264
    PMA / PMN Number
    K143684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RECEIVED AND NO RADIOGRAPHS WERE PROVIDED, THE COMPLAINT WAS NOT CONFIRMED. NO BONE QUALITY REPORT COULD BE PROVIDED. NO ROOT CAUSE CAN BE IDENTIFIED HOWEVER BONE QUALITY IS SUSPECTED AS A CAUSE OR CONTRIBUTOR. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. 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)¿ LOSS OF FIXATION..." "...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..." "...ALL LOCK SCREWS SHOULD BE FINAL-TIGHTENED WITH THE COUNTER-TORQUE AND TORQUE T-HANDLE. DO NOT FINAL-TIGHTEN THROUGH COMPRESSION INSTRUMENTS (E.G. C/D RACK AND FIGURE 8 COMPRESSOR) IN THE SET, AS THE ROD MAY NOT BE ABLE TO NORMALIZE TO THE TULIP. BE CAUTIOUS NOT TO OVER COMPRESS OR DISTRACT AS YOU CAN LOOSEN THE SCREWS IN THE SPINE AND POTENTIALLY PULL OUT THE SCREW..."

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE AT TH10-L4. THE PATIENT WAS ASYMPTOMATIC AND IT WAS DISCOVERED DURING A ROUTINE FOLLOW UP THAT ONE OF THE IMPLANTED PEDICLE SCREWS HAD BECOME LOOSE. ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED TO ADDRESS THE LOOSENED PEDICLE SCREW AT L2. IN THE REVISION SURGERY, PEDICLE SCREWS FROM L2 TO L4 WERE REPLACED WITH NEW ONES AND NEW PEDICLE SCREWS WERE ADDED AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669877 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 16025540 00887517556264

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention