MAUDE Adverse Event Report: NUVASIVE, INC. ARCHON ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; construct remains implanted.Pseudarthrosis has been noted at two of the three construct levels.Patient history is notable for lifestyle choices and post-operative care compliance.These may be contributors to the reported event.Labeling review: ".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)." ".Patients who smoke have been shown to have an increased incidence of pseudarthrosis.".
Event or Problem Description
On (b)(6) 2015 a (b)(6) years old female patient underwent a 3 level procedure on c3 to c4 and c5 to c7.During a 3 month follow up appointment, it was discovered there was a possible loosening of the screws at c7.At the 12 month follow up it was confirmed that the screws loosened at c7 and showed inferior migration.The backed out screws remain in the patient.No revision is planned.No patient injury has been reported.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6358510
• Report Number: 2031966-2017-00012
• Device Sequence Number: 13697231
• Product Code: KWQ
• UDI-Device Identifier: 00887517202338
• UDI-Public: 00887517202338
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• 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: 51 YR