BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 12636201 · Received October 14, 2021

    Report

    Report Number
    2031966-2021-00142
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    October 6, 2021
    Report Date
    December 16, 2021
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    NKB
    UDI-DI
    00887517589064
    PMA / PMN Number
    K182974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED BUT PHOTOGRAPHS WERE PROVIDED TO CONFIRM THE COMPLAINT. IT WAS REPORTED THE PATIENT HAD HARD BONE. WHILE THE ROOT CAUSE COULD NOT BE CONFIRMED THE INFORMATION PROVIDED SUGGESTS EXCESSIVE ROTATIONAL FORCE AS A RESULT OF EXTREMELY SCLEROTIC BONE. NO ADDITIONAL INVESTIGATION REQUIRED. LABEL REVIEW "...POTENTIAL ADVERSE EVENTS AND COMPLICATIONS - 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..." "...COMPLICATIONS TO THE PATIENT MAY INCLUDE, BUT ARE NOT LIMITED TO: BREAKAGE OF THE DEVICE, WHICH COULD MAKE NECESSARY REMOVAL DIFFICULT OR SOMETIMES IMPOSSIBLE..." "... PRE-OPERATIVE WARNING - CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." "...INTRA-OPERATIVE WARNINGS - 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..."

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND THE COMPLAINT WAS CONFIRMED. EXAMINATION OF THE RETURNED DRIVER FOUND A A HIGH TORSIONAL LOAD, LOW CYCLE FRACTURED TIP CONSISTENT WITH EXCESSIVE FORCE. PATIENT WAS NOTED AS HAVING SCLEROTIC BONE. THE ROOT CAUSE IS CONSIDERED TO BE THE RESULT OF OFF AXIS EXCESSIVE TORQUE AND POSSIBLY RELATED TO THE PATIENTS IDENTIFIED HARD BONE AND SURGICAL TECHNIQUE. NO ADDITIONAL INVESTIGATION REQUIRED. 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. DO NOT USE THESE INSTRUMENTS FOR ANY ACTION FOR WHICH IT WAS NOT INTENDED SUCH AS HAMMERING, PRYING, OR LIFTING. 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..." "...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..."

    Description of Event or Problem · 0

    ON (B)(6) 2021 A PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE FROM L2-L4. DURING THE PROCEDURE THE DISTAL TIP OF AN ENGAGED DRIVER FRACTURED OFF INTO A SCREW HEAD ON THE LEFT SIDE AT L3. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. POST-OPERATIVE MRI IMAGES SHOWED HALATION AND THE SALES REP DISCOVERED THE DRIVER TIP HAD FRACTURED OFF. ON (B)(6) 2021 A REVISION OCCURRED TO REMOVE THE FRACTURED DRIVER TIP THAT RESULTED IN THE WHOLE SCREW NEEDING TO BE REPLACED DUE TO AN INABILITY TO FREE THE FRACTURED PORTION. THE REVISION WAS COMPLETED WITHOUT ISSUE AND THE PATIENT IS REPORTED TO BE RECOVERING WELL.

    Description of Event or Problem · 0

    UPDATED INFORMATION LISTED IN SECTION H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533787 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22 NKB NUVASIVE, INCORPORATED 10000831 EM8302 00887517589064
    1533793 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22 NKB NUVASIVE, INCORPORATED 10000831 EM8302 00887517589064

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male