MAUDE Adverse Event Report: NUVASIVE, INC. GSB GLOBAL SPINAL BALANCE SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/31/2015
Type of Reportable Event	Death
Additional Manufacturer Narrative
No information related to the report has been received with respect to usage or device malfunction that may have contributed to the patient's death.No malfunctions were reported that correspond to the reported surgery date.Review of labeling notes: 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.
Event or Problem Description
A female patient (age unknown) underwent a spinal procedure involving posterior fixation on (b)(6) 2015.On (b)(6) 2015, the patient was reported to have expired following an hemothorax event.No other information is known.
Additional Manufacturer Narrative
Additional information was obtained 01/30/2017 via mdr 1723170-2015-00485 indicating a medtronic navigation system was in use during the patient's surgery.The navigation device was reportedly connected to nuvasive instruments.The surgeon reported a "1cm inaccuracy".It is not known if the inaccuracy was encountered as a result of the combination of the medtronic navigation system and nuvasive instruments.It is not known if said inaccuracy resulted in injury; however, the surgery was reported to have continued without delay after use of the medtronic navigation system was discontinued.No information has been received indicating malfunction or performance deterioration of a nuvasive device during surgery.No operative reports have been received that would allow nuvasive to further evaluate the reported event.
Event or Problem Description
A female patient (age unknown) underwent a spinal procedure involving posterior fixation on (b)(6) 2015.On (b)(6) 2015, the patient was reported to have expired following a hemothorax event.No other information is known.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA 92121
• MDR Report Key: 6068434
• Report Number: 2031966-2016-00077
• Device Sequence Number: 13575078
• Product Code: NKB
• UDI-Device Identifier: 00887517596246
• UDI-Public: 00887517596246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2017

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: Physician
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death