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

Model Number	15455300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for investigation nor were radiographs provided to confirm the event.Information received from the physician indicates patient was diagnosed with pseudoarthrosis 15 months post initial surgery.Labeling review: ".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: bending, fracture or loosening of implant component(s).".
Event or Problem Description
On (b)(6) 2016, patient heard a "pop" and was experiencing back pain.Patient was diagnosed with "a broken rod".It was reported a ct scan of the spine indicated a fracture of the connector rods.On (b)(6) 2016, patient underwent revision surgery to remove the fractured rod and revise the instrumentation.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6704687
• Report Number: 2031966-2017-00080
• Device Sequence Number: 43473
• Product Code: NBK
• UDI-Device Identifier: 00887517594181
• UDI-Public: 00887517594181
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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: No Information
• Device Model Number: 15455300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR