BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE GENERAL INSTRUMENTS

    MDR report key: 19101183 · Received April 12, 2024

    Report

    Report Number
    2031966-2024-00107
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 19, 2024
    Report Date
    April 12, 2024
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: IT IS UNKNOWN WHICH INSTRUMENT WAS ASSOCIATED WITH THE REPORTED EVENT: [PART #6900930, LOT #FD4699502, UDI (B)(4)], [PART #6900931, LOT #FD2384909, UDI (B)(4)], [PART #6904414, LOT #FD1856001, UDI (B)(4)], [PART #6904415, LOT #FD2385706, UDI (B)(4)], [PART #6999104, LOT #FD8131807, UDI (B)(4)], [PART #7131041, LOT #FD4669911, UDI (B)(4)], [PART #7131042, LOT #FD4669912, UDI (B)(4)]. H4: 06JAN2023, 27NOV2020, 06APR2011, 23NOV2020, 25AUG2018, 10AUG2015, OR 10AUG2015 THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED CONCERNING THIS EVENT. THERE WAS NO PRODUCT FAILURE ALLEGED AS PART OF THE REPORTED EVENT; FURTHER, NO OPERATIVE NOTES, MEDICAL RECORDS, AND/OR RADIOGRAPH IMAGES WERE 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. LABELING REVIEW: "¿RESIDUAL RISKS AND POTENTIAL SIDE EFFECTS: 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 INCLUDE: DAMAGE TO BLOOD VESSELS...RARELY, SOME COMPLICATIONS MAY BE FATAL..." "...RESIDUAL RISKS TO THE PATIENT ASSOCIATED WITH USE OF GENERAL SURGICAL INSTRUMENTS ARE: RISKS INHERENT TO INVASIVE SURGICAL PROCEDURES ASSOCIATED WITH SITE ACCESS AND PREPARATION WHICH CANNOT BE ELIMINATED. THESE RISKS INCLUDE...VASCULAR INJURY..." "...PATIENT EDUCATION: PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY..." "...PRE-OPERATIVE WARNINGS: THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES...DO NOT USE THESE INSTRUMENTS FOR ANY ACTION FOR WHICH IT WAS NOT INTENDED SUCH AS HAMMERING, PRYING, OR LIFTING...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..." 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TWO (2) LEVEL EXTREME LATERAL INTERBODY FIXATION PROCEDURE USING THE CRESTLINE TECHNIQUE AT L3/4 AND L4/5. DURING THE PROCEDURE, FOLLOWING COMPLETION OF THE L3/4 LEVEL AND PLACEMENT OF THE RETRACTOR AT THE L4/5 LEVEL, THE COMMON ILIAC VEIN WAS DAMAGED DURING DISC DISSECTION, RESULTING IN BLOOD LOSS. THE INTERBODY WAS PLACED IN THE DISC SPACE WHILE MAINTAINING HEMOSTASIS AND THE INCISION WAS CLOSED TEMPORARILY IN ORDER TO REPOSITION THE PATIENT. HEMOSTASIS WAS THEN APPLIED BY THE SURGEON. IT IS UNKNOWN HOW MUCH BLOOD WAS LOST AND IF TRANSFUSION WAS REQUIRED. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469344 NUVASIVE GENERAL INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE, INC. SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other