MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II SYSTEM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	7284545
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not received to confirm the event.No product has been returned for investigation as product remains in patient.The root cause cannot be determined at this time.Labeling review: potential adverse events and complications "potential risk identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation.".In situ.
Event or Problem Description
On (b)(6) 2009, a female patient underwent a posterior fusion procedure.On (b)(6) 2017, patient reported a ct scan indicates screws may have loosened.No revision surgery is planned at this time.

• Brand Name: NUVASIVE SPHERX II SYSTEM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6636966
• Report Number: 2031966-2017-00058
• Device Sequence Number: 613964
• Product Code: MNH
• UDI-Device Identifier: 00887517461698
• UDI-Public: 00887517461698
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/12/2017

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: 7284545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Initial Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1