MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE X-CORE II ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180041A

Device Problems Collapse (1099); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

The reported device has been received by nuvasive and the investigation is currently in process.Once the investigation has been completed, a supplemental report will be filed accordingly.

Event Description

It was reported that a few months after the index procedure, an x-core 2 vertebral body replacement implant was found to have decreased in height.The patient had developed increasing pain during rehabilitation and subsequent x-rays found the decrease in implant height.It was reported the patient was compliant with post-operative instructions and did not experience any falls or other traumatic events.A revision procedure was performed to address the reported issue and the implant was removed and replaced with another x-core 2 device.It was reported the revision was successful and the patient is mobile with conditions significantly improved.

Manufacturer Narrative

Radiographs provided confirmed the event.The returned device was examined where substantial damage to the auto lock pin, gear sleeve teeth and inserter interface was identified but unable to determine if the damage was the result of incomplete inserter attachment or incurred during collapse and removal.(note the inserter was not provided for examination).Additionally examination found no lock screw smear on the center core confirming final lock screw engagement was completed.(note final lock screw driver was not provided).Testing completed on the device found it to be fully functional even in its current state and was able to be locked down into any position, no product malfunction could be recreated.The information hear suggests auto lock damage incurred and incomplete lock screw engagement combined in addition to patient load and activity induced the collapse.No additional investigation can be completed.Labeling review: ".Warnings, cautions and precautions: 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." ".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.In order to ensure proper inserter/implant engagement, the inserter¿s colored distal tip must face up toward the like-colored spinning sleeve of the implant.To ensure proper anatomical alignment, the rounded corners of the x-core shape endcaps must face anterior during implant construction and placement.Care should be taken to insure that all components are ideally fixated prior to closure." ".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.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.It is important to instruct the patient in appropriate postoperative activity restrictions to minimize the risk of potential vertebral body fracture and implant migration." ".Method of use:please refer to the surgical technique for this device." ".Step 6: final tightening 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 core set screw and rotate clockwise until it breaks away.It will torque off at 10 in.-lb.".

Event Description

Implant received and examined.Additional information listed in section h10.

• Brand Name: NUVASIVE X-CORE II ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13766267
• MDR Text Key: 292381979
• Report Number: 2031966-2022-00058
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00887517365835
• UDI-Public: 887517365835
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7180041A
• Device Catalogue Number: N/A
• Device Lot Number: NN2451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 7110002 SET SCREW DRIVER; 7185100 INSERTER; X-CORE 2 TI ENDCAP, QTY 2
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 65 KG