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

Model Number	16015535
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/08/2018
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8042952
• Report Number: 2031966-2018-00160
• Device Sequence Number: 13811748
• Product Code: NKB
• UDI-Device Identifier: 00887517553201
• UDI-Public: 00887517553201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 16015535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Death