BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE MAS SYSTEM

    MDR report key: 17007269 · Received May 25, 2023

    Report

    Report Number
    2031966-2023-00120
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 3, 2023
    Report Date
    May 25, 2023
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517513717
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED TO NUVASIVE FOR EVALUATION; THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF A PHOTOGRAPH OF THE FRACTURED DEVICE. THE TORQUE HANDLE USED, OPERATIVE NOTES, AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF DEVICE MANUFACTURING RECORDS WAS PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED; HOWEVER, MAY HAVE RESULTED FROM EXCESSIVE FORCE APPLIED BY THE TORQUE HANDLE OR THE USER. LABELING REVIEW: "PRE-OPERATIVE WARNINGS: IMPLANTS AND INSTRUMENTS SHOULD BE PROTECTED DURING STORAGE AND FROM CORROSIVE ENVIRONMENTS. REFER TO CLEANING AND STERILIZATION INSTRUCTIONS BELOW FOR ALL NON-STERILE PARTS. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT" "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. SURGICAL GRADE INSTRUMENT LUBRICATION SHOULD BE APPLIED TO ALL MOVING COMPONENTS DURING THE WASH AND STERILIZATION CYCLE TO ENSURE PROPER FUNCTIONALITY. 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. 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." IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    DURING A PROCEDURE, THE DRIVER TIP FRACTURED OFF WHILE FINAL TIGHTENING THE LOCK SCREW. THE FRACTURED PORTION COULD NOT BE RETRIEVED AND THEREFORE REMAINS IN THE PATIENT; HOWEVER, THE FRACTURED PORTION WAS REPORTED TO BE LODGED WITHIN THE LOCK SCREW. THERE WAS NO DELAY IN SURGERY AND THERE HAS BEEN NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849050 NUVASIVE RELINE MAS SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE, INC. 10000750 NM3941 00887517513717

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male RELINE LOCK SCREW