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

Model Number	7460612
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/14/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The revision surgery which corrected the loosened screw subsequently led to fusion.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) 2014 a (b)(6) year old male patient had 4 level procedure from c3 to c7.During the 12 month follow up it was discovered via radiograph that there was a backout of a screw at the lower end of the construct.On (b)(6) 2015 the patient underwent a revision surgery to address the backout.A follow up appointment on (b)(6) 2015 revealed the patient is doing fine post revision and that spinal fusion has occurred.No patient injury was 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: 6350159
• Report Number: 2031966-2017-00008
• Device Sequence Number: 18998635
• Product Code: KWQ
• UDI-Device Identifier: 00887517487223
• UDI-Public: 00887517487223
• 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: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 7460612
• 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: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR