BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE GENERAL INSTRUMENTS

    MDR report key: 12747329 · Received November 3, 2021

    Report

    Report Number
    2031966-2021-00151
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 29, 2021
    Report Date
    January 28, 2022
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    LHX
    UDI-DI
    00887517476005
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED AS THE DEVICE WAS DISPOSED OF AT THE FACILITY, A PHOTOGRAPH WAS PROVIDED CONFIRMING THE DRIVER TIP FRACTURE. EXAMINATION OF THE PROVIDED PHOTOGRAPH NOTED WHAT APPEARS TO BE A HIGH LOAD TORSIONAL FRACTURE AND LIKELY THE RESULT OF EXCESSIVE TORQUE. A BONE QUALITY REPORT COULD NOT BE PROVIDED. REVIEW OF THE REPORTED EVENT IDENTIFIED THAT THE NUVASIVE WAS BEING UTILIZED WITH ANOTHER MANUFACTURES IMPLANT FOR WHICH REQUIREMENTS FOR ARE UNKNOWN. NO ADVERSE EFFECTS TO THE PATIENT REPORTED. LABELING REVIEW: "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." "CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT." "METHOD OF USE: IF THERE IS ANY DOUBT OR UNCERTAINTY CONCERNING THE PROPER USE OF INSTRUMENTS PLEASE CONTACT NUVASIVE CUSTOMER SERVICE. ANY AVAILABLE SURGICAL TECHNIQUES WILL BE PROVIDED UPON REQUEST. FOR OPTIMAL RESULTS, THE SAME TYPE OF INSTRUMENTS USED FOR IMPLANTATION SHOULD BE USED FOR IMPLANT REMOVAL."

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED AS THE DEVICE WAS DISPOSED OF AT THE FACILITY BUT A PHOTOGRAPH WAS PROVIDED CONFIRMING THE ALLEGED DRIVER TIP FRACTURE. NO ADVERSE EFFECTS TO THE PATIENT REPORTED. A BONE QUALITY REPORT COULD NOT BE PROVIDED. REVIEW OF THE REPORTED EVENT IDENTIFIED THAT THE NUVASIVE WAS BEING UTILIZED WITH ANOTHER MANUFACTURES IMPLANT WHICH IS CONSIDERED TO BE OFF LABELED USAGE AS DEVICE COMPATIBILITY IS UNKNOWN WHILE UTILIZING WITH COMPETITORS DEVICES. NO ADDITIONAL INVESTIGATION NEEDED. LABEL REVIEW: "COMPATIBILITY: DO NOT USE NUVASIVE INSTRUMENTS WITH COMPONENTS OF OTHER SYSTEMS. UNLESS STATED OTHERWISE, NUVASIVE DEVICES ARE NOT TO BE COMBINED WITH THE COMPONENTS OF ANOTHER SYSTEM." "CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT."

    Description of Event or Problem · 0

    CORRECTED INFORMATION LISTED IN H10.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE A PREVIOUSLY IMPLANTED COMPETITORS SCREW. DURING THE PROCEDURE THE TIP OF THE NUVASIVE REMOVAL TOOL THAT WAS BEING USED FRACTURED OFF AND WAS RETRIEVED BUT NO ADDITIONAL REPLACEMENT INSTRUMENT WAS AVAILABLE. THE CASE WAS DELAYED FOR ABOUT 30 MINUTES BEFORE IT WAS DECIDED TO CANCEL. AN ADDITIONAL REVISION SURGERY IS BEING PLANNED BUT IS NOT SCHEDULED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640386 NUVASIVE GENERAL INSTRUMENTS ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS LHX NUVASIVE, INCORPORATED HD203T25 00887517476005

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male