MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7450716
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/24/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Radiographic confirmation was not available; the fracture was noted in the clinical summary received.No actions were taken to correct the reported event.Review of labeling notes: ".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".".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." device not returned.
Event or Problem Description
On (b)(6) 2013 a (b)(6) year old male patient underwent a 4 level procedure from c4 to t1 spine levels.The 12-month follow-up notes indicate fracture of two screws at the t1 level.The fractured screws remain in the patient.No revision is planned.No patient injury has been reported.

• Brand Name: NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6358374
• Report Number: 2031966-2017-00014
• Device Sequence Number: 578798
• Product Code: KWQ
• UDI-Device Identifier: 00887517482143
• UDI-Public: 00887517482143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: Physician
• Device Model Number: 7450716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR