MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE HELIX REVOLUTION ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7803115
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Failure of Implant (1924); Perforation of Esophagus (2399)
Date of Event	02/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No radiographs were provided to confirm the event.The explanted construct was not returned for evaluation.The subcutaneous air was not reported to have occurred prior to the revision.The subcutaneous air reportedly was resolving following the repair of the esophageal perforation, although as of the last report date, the patient was experiencing dysphagia.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 include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves, pulmonary emboli; loss of sensory and/or motor function; and permanent pain and/or deformity.Rarely, some complications may be fatal." device remains in-situ.
Event or Problem Description
On (b)(6) 2016 a (b)(6) year-old male underwent a revision procedure due to adjacent segment degeneration with the goal of extending the fusion construct from the original c5-c7 to include c3-c4 levels.During evaluation it was noted that a screw implanted in the c7 vertebral body had loosened and backed out.Following what was reported to be a smooth surgery, the patient developed subcutaneous emphysema secondary to esophageal perforation.The perforation was repaired (b)(6) 2016.

• Brand Name: NUVASIVE HELIX REVOLUTION ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5481796
• Report Number: 2031966-2016-00005
• Device Sequence Number: 16235439
• Product Code: KWQ
• UDI-Device Identifier: 00887517138934
• UDI-Public: 00887517138934
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 7803115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• Initial Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR