MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE X-CORE EXPANDABLE VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180033AP2

Device Problem Collapse (1099)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

On (b)(6) 2022, a patient underwent a spinal procedure.On (b)(6) 2023, during a follow up a loss of height of the implant was discovered.A revision surgery is currently not scheduled.

Manufacturer Narrative

No product was returned as it is still in-situ.Radiographs provided confirmed the complaint.Patient's post-operative physical activity is unknown.Review of the radiographs was unable to determine failure mode so no root cause can be determined however review of the historical data suggests auto lock damage or failure in addition to insufficient manual lock screw final torque as probable cause or contributors.No additional investigation can be completed at this time.No revision is planned.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformance with respect to material type, treatments or dimensions that may have caused or contributed to this failure mode.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: loss of fixation." "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.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." "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: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.".

Manufacturer Narrative

Additional information: d4 (lot number), h4, h6 (type of investigation), h10 correction: h6 (investigation findings) manufacturing record review: review of manufacturing records for lot ml01044 found no material non-conformances, no manufacturing errors, and no discrepancies that may have caused or contributed to the reported event.The lot met all release criteria.

Event Description

N/a.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16400803
• MDR Text Key: 310069647
• Report Number: 2031966-2023-00021
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00887517685087
• UDI-Public: 887517685087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193506
• 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: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7180033AP2
• Device Lot Number: ML01044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose