MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7160022P2
Medical Device Problem Codes	Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 a patient underwent a vertebral body replacement procedure on unknown levels of the spine.During the procedure a vertebral replacement implant was placed and distracted.The surgeon then removed the distracted implant and repositioned it but now it failed to distract.Another larger implant was implanted and it too failed to distract.A third even larger implant was utilized without issue.There were no adverse complications to the patient as a consequence of the device failures.
Additional Manufacturer Narrative
No product was returned confirming the alleged complaint.Review of the reported information provided as well as review of previous similar events suggests the damage observed is consistent with incorrect engagement rotation, or improper implant size selection.No lot code information was provided so a complete manufacturing review could not be completed.No additional investigation can be completed at this time.Label review ¿¿ warnings, cautions and precautions - correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant¿¿ ".Once the core is either in its fully compressed or fully expanded state, do not continue to rotate the teardrop handle.Over-expanding or over compressing may result in implant stripping." ".Upon final confirmation that implant is at desired height, use the core lock screw driver to lock the construct into place.Engage the core lock screw driver onto the set screw of the core and rotate clockwise until the driver breaks away.It will torque off at 10 in.-lb.(figs.39-41)." ".Should implant removal be required, unlock the set screw with the set screw driver, and turn the set screw approximately â½ turn counterclockwise (fig.43).Note: only a â½ turn is required to release the set screw.If backed out too far, the set screw may prevent the inserter from properly re-engaging the core.".
Additional Manufacturer Narrative
The devices were received by nuvasive and the complaint was not confirmed as failed to distract but rather the lock screw was engaged prior to the attempted expansion.The device was examined, and gear sleeve contact damage was found on all teeth additionally 5 teeth were completely deformed or broken off.The lock screw weld was broken, and the lock screw was applied with force locking the core from expanding.The device was then attached to the inserter and was unable to expand however, the lock screw was then backed out to the neutral position and the core was easily able to be expanded and contracted without issue.The observed functionality is consistent with the lock screw deployment prior to the expansion process which restricted the device from expanding and being damaged by the inserter as a result.No further investigation required.Manufacturing review: review of the device history record notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." ".All components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur." "single use/do not re-use: reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachable, and transmission of infectious agents." "pre-operative warnings.3.Care should be used in the handling and storage of the x-core implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the x-core implant from its packaging.Inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the x-core implants if there is any evidence of damage.4.Refer to cleaning and sterilization instructions below for all non-sterile parts.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." 9400903-en m-2022-12 ".Once the core is either in its fully compressed or fully expanded state, do not continue to rotate the teardrop handle.Over-expanding or over compressing may result in implant stripping." ".Upon final confirmation that implant is at desired height, use the core lock screwdriver to lock the construct into place.Engage the core lock screwdriver onto the set screw of the core and rotate clockwise until the driver breaks away.It will torque off at 10 in.-lb.(figs.39-41) ¿" ".Should implant removal be required, unlock the set screw with the set screwdriver, and turn the set screw approximately a ½ turn counterclockwise (fig.43).Note: only a ½ turn is required to release the set screw.If backed out too far, the set screw may prevent the inserter from properly re-engaging the core." 9500968 c new and updated information found on sections b4, d4, d9, d10, e4, g3, g6, h2, h3, h4, h6, and h10.
Event or Problem Description
New and updated information listed on section h10.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffry gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17651995
• Report Number: 2031966-2023-00181
• Device Sequence Number: 6332066
• Product Code: MQP
• UDI-Device Identifier: 00887517684936
• UDI-Public: 887517684936
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K193506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7160022P2
• Device Lot Number: ST128789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: D7165100 INSERTER LOT EM9267
• Patient Sex: Prefer Not To Disclose