BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE GENERAL INSTRUMENTS

    MDR report key: 16542680 · Received March 15, 2023

    Report

    Report Number
    2031966-2023-00045
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 14, 2023
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    LHX
    UDI-DI
    00887517354143
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE HAS BEEN RETURNED FOR EVALUATION AND NO RADIOGRAPHS WERE PROVIDED TO CONFIRM THE UNRETRIEVED FRAGMENT COMPLAINT. REVIEW OF THE REPORTED INFORMATION SUGGESTS OFF-ANGLED EXCESSIVE FORCE AND/OR POTENTIAL PATIENT RELATED FACTORS SUCH AS SCLEROTIC BONE AS THE POSSIBLE ROOT CAUSE. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED AT THIS TIME, SHOULD MORE INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE COMPLETED. LABEL REVIEW: "WARNINGS, CAUTIONS AND PRECAUTIONS: THE IMPLANTATION OF PEDICLE SCREW SPINAL SYSTEMS SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS PEDICLE SCREW SPINAL SYSTEM BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT." "CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." "PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE POTENTIAL RISKS OF THE SURGERY." "DO NOT IMPLANT THE INSTRUMENTS: COMPLICATIONS TO THE PATIENT MAY INCLUDE, BUT ARE NOT LIMITED TO: BREAKAGE OF THE DEVICE, WHICH COULD MAKE NECESSARY REMOVAL DIFFICULT OR SOMETIMES IMPOSSIBLE, WITH POSSIBLE CONSEQUENCES OF LATE INFECTION AND MIGRATION. BREAKAGE COULD CAUSE INJURY TO THE PATIENT." ".PRE-OPERATIVE WARNINGS: THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES. THE INSTRUMENTS SHOULD BE TREATED AS ANY PRECISION INSTRUMENT AND SHOULD BE CAREFULLY PLACED ON TRAYS, CLEANED AFTER EACH USE, AND STORED, ACCORDING TO GENERALLY ACCEPTED HOSPITAL METHODS AND PRACTICES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." "INTRA-OPERATIVE WARNINGS: THE PHYSICIAN SHOULD TAKE PRECAUTIONS AGAINST PUTTING UNDUE STRESS ON THE SPINAL AREA WITH INSTRUMENTS. ANY SURGICAL TECHNIQUE SHOULD BE CAREFULLY FOLLOWED. IT IS IMPORTANT THAT THE SURGEON EXERCISE EXTREME CAUTION WHEN WORKING IN CLOSE PROXIMITY TO VITAL ORGANS, NERVES, OR VESSELS, AND THAT THE FORCE APPLIED TO THE INSTRUMENTATION IS NOT EXCESSIVE, TO PREVENT POTENTIAL INJURY TO THE PATIENT. OVER-BENDING, NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE. WHEN USING THE MAXCESS MAS TLIF SYSTEM FOR DISTRACTION CARE MUST BE TAKEN TO AVOID DAMAGING THE PEDICLES WHICH COULD COMPROMISE PEDICLE SCREW PURCHASE. THE PHYSICAL CHARACTERISTICS REQUIRED FOR MANY INSTRUMENTS DO NOT PERMIT THEM TO BE MANUFACTURED FROM IMPLANTABLE MATERIALS. IF ANY BROKEN FRAGMENTS OF INSTRUMENTS REMAIN IN THE BODY OF A PATIENT, THEY COULD CAUSE ALLERGIC REACTIONS OR INFECTIONS. IF AN INSTRUMENT BREAKS IN SURGERY AND FRAGMENTS GO INTO THE PATIENT, THESE PIECES SHOULD BE REMOVED PRIOR TO CLOSURE AND SHOULD NOT BE IMPLANTED." DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    ON FEBRUARY 28TH 2023 A PATIENT UNDERWENT A POSTERIOR FIXATION PROCEDURE FROM L3 TO L5. DURING THE PROCEDURE WHILE TAPPING THE RIGHT VERTEBRAL BODY AT L3 THE TIP OF THE TAP FRACTURED OFF FLUSH INTO THE BONE. THE SURGEON DETERMINED THIS WAS NOT A RISK TO THE PATIENT AND LEFT THE FRACTURED PORTION IN SITU. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE DEVICE FAILURE AND THE SURGERY WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914898 NUVASIVE GENERAL INSTRUMENTS ORTHOPEDIC MANAL SURGICAL INSTRUMENTS LHX NUVASIVE, INCORPORATED 8801355 NI 00887517354143

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male