BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE PRECEPT SPINAL SYSTEM

    MDR report key: 11772948 · Received May 4, 2021

    Report

    Report Number
    2031966-2021-00062
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 4, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    88751734996
    PMA / PMN Number
    K171894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PROVIDED RADIOGRAPH CONFIRMED THE COMPLAINT. THE PATIENT WAS ASYMPTOMATIC FOR OVER TWO YEARS AND FUSION WAS CONFIRMED BEFORE IDENTIFICATION OF THE FRAGMENT. THE RETRIEVED FRAGMENT MAY RELATE TO A POSSIBLE GUIDE FRACTURE AND UN-RETRIEVED FRAGMENT FROM THE INDEX PROCEDURE THAT OCCURRED ON (B)(6) 2019. THAT WENT UNRECOGNIZED UNTIL HARDWARE REMOVAL PLANNING. NO DEVICE WAS RETURNED HOWEVER REVIEW OF REPS INDEX PROCEDURE POST OP NOTES REVEALED A FRACTURED GUIDE WAS IDENTIFIED BUT NOT CONFIRMED BY NUVASIVE. NO ROOT CAUSE COULD BE DETERMINED ALTHOUGH THE SUGGEST GUIDE FRACTURE IS MOST LIKELY THE RESULT OF EXCESSIVE OFF ANGLE FORCE. NO ADDITIONAL INVESTIGATION REQUIRED. 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..." "...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. &" "...PRE-OPERATIVE WARNINGS...CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT&" .

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT A SPINAL PROCEDURE. BONE FUSION WAS ACHIEVED SO IT A REMOVAL SURGERY WAS SCHEDULED. AN X-RAY WAS TAKEN FOR THE REMOVAL SURGERY AND A FLOATING METAL PIECE WAS FOUND IN THE TISSUE NEAR THE SCREW HEAD AT L5. ON (B)(6) 2021, THE HARDWARE REMOVAL SURGERY TOOK PLACE AND AT THAT TIME THE METAL PIECE WAS REMOVED FROM THE PATIENT AS WELL. WHILE THE ORIGIN OF THE FRACTURED PIECE REMAINS UNCONFIRMED IT WAS BELIEVED THAT THE METAL PIECE MAY BE A PART OF A INSTRUMENT USED IN THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669469 NUVASIVE PRECEPT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE, INCORPORATED 8801208 88751734996

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention