MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Embolism/Embolus (4438)

Event Date 02/25/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a underwent a extreme lateral interbody fusion procedure from l1-l5 where a competitors cages were implanted.On (b)(6) 2022 the secondary portion of the extreme lateral interbody fusion procedure occurred from t10-s2ai where a nuvasive reline construct was installed while two additional competitor¿s cages were inserted.At an unknown date post op it was reported that the patient complained of pain in the left leg and while in the standing position.As a consequence on (b)(6) 2022 patient had a revision surgery where a blood clot near the midline of l4/5 was removed.The patient is reported to no longer in pain after the revision surgery.

Manufacturer Narrative

No product was received or returned as no product malfunction was reported and the involved devices currently remain in situ.No radiographs or testing data was provided confirming the reported blood clot.The root cause of the event is unknown but could be the result of inadvertent contact and tissue damage.Note nuvasive posterior fixation was utilized in conjunction with another manufactures cages and likely is a cause or contributor, and is considered to be off label usage.No additional investigation can be completed at this time.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 include: damage to blood vessels." ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury, pain, discomfort or abnormal sensations due to the presence of the device." ".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." ".Compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system.All implants should be used only with the appropriately designated instrument (reference surgical technique)¿".

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13869594
• MDR Text Key: 293080276
• Report Number: 2031966-2022-00061
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K143684
• 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
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 02/25/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG