BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCESS 4 ARTICULATING ARM

    MDR report key: 18178782 · Received November 20, 2023

    Report

    Report Number
    2031966-2023-00274
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 31, 2023
    Report Date
    November 20, 2023
    Manufacturer
    NUVASIVE, INC.
    Product Code
    LXH
    UDI-DI
    00887517196668
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED TO NUVASIVE FOR EVALUATION. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING RECORDS WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. 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..." "...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... 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..." 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 DURING A PROCEDURE, THE RETRACTOR ATTACHMENT COMPONENT BROKE OFF OF THE ARM. THERE WAS NO REPORTED ADVERSE PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992232 MAXCESS 4 ARTICULATING ARM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH NUVASIVE, INC. 3240121 NI 00887517196668

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose