MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8452500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/01/2010
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor have radiographs been provided to confirm the reported event.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)." "nonunion or delayed union." no product returned.
Event or Problem Description
Received information from patient stating he was informed of screw loosening and was seeking advice from nuvasive to consult with surgeon in regards to current situation.No revision surgery has been reported.

• Brand Name: NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6748511
• Report Number: 2031966-2017-00095
• Device Sequence Number: 1063463
• Product Code: NKB
• UDI-Device Identifier: 00887517266514
• UDI-Public: 00887517266514
• Combination Product (Y/N): N
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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: 8452500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1