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

Model Number	7450614
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/02/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.The post-impact evaluation noted fusion with the exception of c6-c7; pseudarthrosis was considered probable.Revision surgery occurred (b)(6) 2015 in which screws were replaced.Additional construct included posterior fusion with translaminar screws and interconnecting rods from c5-t2.In (b)(6) 2015 the patient was reported to have a stable 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)." " delayed union or nonunion: the nuvasive gradient plus plate system is designed to assist in an adequate biomechanical environment for fusion.It is not intended to be and must not be used as the sole support for the spine.If a delayed union or nonunion occurs the implant may fail due to metal fatigue." device not returned.
Event or Problem Description
On (b)(6) 2013 a (b)(6) year old male patient underwent a 4 level procedure on c3 to c7.At a 12 month postoperative appointment the patient reported having sustained a hard fall which resulted in fractured screws at c6 and c7.The patient underwent a revision surgery on 01/13/2015 to replace the damaged screws.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: 6367856
• Report Number: 2031966-2017-00013
• Device Sequence Number: 1008032
• Product Code: KWQ
• UDI-Device Identifier: 00887517481955
• UDI-Public: 00887517481955
• 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
• 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: No Information
• Device Model Number: 7450614
• 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: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR