MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number DM-05-31

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

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 09/30/2019

Event Type  Death  

Manufacturer Narrative

No product malfunction alleged nor radiographs or test results provided.Even though root cause cannot be confirmed, it is unknown if patient related factors may have contributed to alleged event.It is undetermined if a invasive product or procedure caused or contributed to event.Labeling review: " preoperative 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 orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli.Rarely, some complications may be fatal.".

Event Description

On (b)(6) 2019 patient underwent the first of two planned procedures an extreme lateral interbody fusion from l2 to l5 levels without reported issues.On (b)(6) 2019 the secondary procedure was conducted percutaneous posterior fixation from l2 to iliac as well as a posterior lumbar interbody fusion at l5 to s1.As per reporter during the procedure the patient¿s vital signs decrease and the surgeon immediately closed the operative field and conducted cardiac massage.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 9246017
• MDR Text Key: 163969481
• Report Number: 2031966-2019-00248
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517225597
• UDI-Public: 887517225597
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DM-05-31
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 16018560; 16018570; 16027540; 16027545
• Patient Outcome(s): Death
• Patient Age: 74 YR