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

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

Patient Problem Death (1802)

Event Date 01/18/2021

Event Type  Death  

Manufacturer Narrative

No product was returned as no malfunction was alleged.Due to lack of information, the root cause cannot be determined, however review of the reported event indicates the patient's medical history and response to a technically demanding surgery is most likely the root cause.No additional investigation can be completed.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: death.".".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.".".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.".".Contraindications: contraindications include but are not limited to:6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome.

Event Description

On (b)(6) 2021, a patient underwent a posterior fixation procedure at l2/s1.The surgery was reportedly successfully completed.After the patient awakened from anesthesia, a thrombus developed and the patient went into cardiac arrest.The patient was transferred to the icu, but unfortunately passed away on (b)(6) 2021.The physician suggests that there was no causal relationship between the decease and nuvasive products.

• 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: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 11280349
• MDR Text Key: 230310981
• Report Number: 2031966-2021-00024
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160989
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 01/22/2021
• 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): Death