BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE XLIF INSTRUMENTS

    MDR report key: 19374578 · Received May 22, 2024

    Report

    Report Number
    2031966-2024-00140
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 22, 2024
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517452764
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR RADIOGRAPHIC IMAGES WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF DEVICE MANUFACTURING RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE FOUND. BASED ON THE INFORMATION OBTAINED, THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED, BUT MAY HAVE BEEN THE RESULT OF EXCESSIVE USE OF FORCE OR TECHNIQUE. LABELING REVIEW: "RESIDUAL RISKS TO THE PATIENT ASSOCIATED WITH USE OF GENERAL SURGICAL INSTRUMENTS ARE: INSTRUMENT MALFUNCTIONS WHICH POTENTIALLY RESULT IN SURGICAL DELAYS (THEREBY CAUSING ADDITIONAL EXPOSURE TO ANESTHESIA, BLOOD LOSS, AND INFECTION), A CHANGE IN SURGICAL PLAN, FAILURE TO ACHIEVE OPTIMAL CLINICAL RESULT AND/OR, INFREQUENTLY, CANCELLATION OF A PROCEDURE. SUCH MALFUNCTIONS INCLUDE INSTRUMENT FRACTURE, WHICH COULD MAKE NECESSARY REMOVAL DIFFICULT OR SOMETIMES IMPOSSIBLE, WITH POSSIBLE CONSEQUENCES OF LATE INFECTION AND MIGRATION; INSTRUMENT FRACTURE MAY ALSO RESULT IN INJURY TO THE PATIENT." "RESIDUAL RISKS TO SURGICAL STAFF ASSOCIATED WITH USE OF GENERAL SURGICAL SYSTEMS ARE: INSTRUMENT FAILURES OR MALFUNCTIONS WHICH PREVENT INTENDED USE, RESULTING IN DECREASED OPERATIONAL EFFICIENCY AND GENERAL INCONVENIENCE." "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." "INTRA-OPERATIVE WARNINGS: 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 DISTAL ARTICULATING TIP OF THE PITUITARY RONGEUR FRACTURED OFF. THE PIECE WAS RETRIEVED AND WAS NOT RETAINED IN THE PATIENT. NO FURTHER PATIENT OR PROCEDURE IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596713 NUVASIVE XLIF INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE, INC. 6940429 TS0157 00887517452764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown