MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE PULSE SYSTEM

Model Number	5050130
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned inspected, tested and found to be working within nuvasive specifications.The procedure was aborted and another manufacturers product was utilized.The patient is reportedly doing well.The root cause was undetermined at this time.Labeling review: "the pulse system is to be used only as an adjunct to medical judgment and appropriate surgical practices.Dilator insertion and advancement should be conducted only after careful analysis of radiographic images of the operative target area.Do not advance dilator probes until all available data have been considered." "applying excessive force to the instrument arrays when tracking their locations can result in inaccurate measurements due to deflection of the instrument, do not apply excessive force to the instrument arrays.The accuracy of data acquisition can be influenced by the rotation of the passive reflective array relative to the camera.Cameras should be placed such that a direct line of sight to the operative area is established.".
Event or Problem Description
It was reported during a procedure one of the arrays inaccurate and patients pedicle at l4 left side was breached.

• Brand Name: NUVASIVE PULSE SYSTEM
• Common Device Name: NUVASIVE PULSE SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9118374
• Report Number: 2031966-2019-00239
• Device Sequence Number: 14147033
• Product Code: OLO
• UDI-Device Identifier: 00887517994127
• UDI-Public: 887517994127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5050130
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1