MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction was alleged.Product was re-positioned and left in-situ.No radiographs or images provided to confirm the alleged event.Review of the reported event as well as surgeons comments confirm the root cause may be related to unintended use.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.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." ".Pre-operative warnings care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; pleural effusions, hemothorax, chylothorax, pneumothorax, subcutaneous emphysema, need for chest tube insertion, intercostal neuralgia, rib fracture, diaphragm injury; atelectasis; impotence; permanent pain and/or deformity.Rarely, some complications may be fatal.The treatment of multilevel degenerative scoliosis may be associated with a lower interbody fusion rate compared to one and two-level interbody fusions.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union, fracture of the vertebra, neurological, vascular or visceral injury, metal sensitivity or allergic, reaction to a foreign body, infection, decrease in bone density due to stress shielding, pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma.".

Event Description

A patient underwent a transforaminal lumbar interbody fusion at l5/s1 on (b)(6) 2020.It was reported that the cage popped out to anterior side of vertebral body.The physician utilized the removal tool to retrieve the cage and re located it to a suitable location.

• Brand Name: NUVASIVE COROENT SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 9826538
• MDR Text Key: 188117503
• Report Number: 2031966-2020-00037
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other