MAUDE Adverse Event Report: NUVASIVE INC. GSB GLOBAL SPINAL BALANCE SYSTEM

Model Number 16015535

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

Patient Problem Death (1802)

Event Date 10/08/2018

Event Type  Death  

Manufacturer Narrative

No product has been returned for evaluation as it remained in-situ.No allegation of product malfunction reported nor were x-ray films provided.All nuvasive devices utilized in this case were cleaned and sterilized by the user facility.No additional information has been provided therefore, no further investigation could be completed at this time.Labeling review: ".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, bursitis, dural leak paralysis, death." ".The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious 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: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal.".

Event Description

On (b)(6) 2018, a patient underwent a posterior spinal fusion at levels t11-l3 without any reported issues.On (b)(6) 2018 patient expired due to sepsis shock.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Type of Device: GSB GLOBAL SPINAL BALANCE 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: 8042952
• MDR Text Key: 126282856
• Report Number: 2031966-2018-00160
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517553201
• UDI-Public: 00887517553201
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16015535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2018
• 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
• Treatment: RELINE LOCK SCREW 5.5MM 13550000; RELINE MAS SCREW 5.5X40MM 2C 16015540; RELINE MAS SCREW 6.5X40MM 2C 16016540; RELINE MAS TI ROD 5.5X120MM 11355120
• Patient Outcome(s): Death