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

Model Number	8780417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930); Pain (1994)
Date of Event	01/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Treatment of the reported event involved wound debridement and treatment with iv antibiotics.The infection was reportedly resolved without further action.".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: infection." device not returned.
Event or Problem Description
On (b)(6) 2015 a (b)(6) year-old male patient underwent a 4-level acdf procedure from c3 to c7.Six months after index surgery the patient fell, after which the patient reported increased cervical pain.A mri showed spinal canal narrowing at c4 and c5 with evidence of edema.Ct images demonstrated subsidence of c3 interbody graft.As a result of the impact, instability increased; a posterior cervical fusion construct was added on (b)(6) 2016.The revision surgery was complicated by a post-operative infection requiring wound debridement and iv antibiotics.Patient has recovered from the reported infection.

• 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: 6430518
• Report Number: 2031966-2017-00023
• Device Sequence Number: 779962
• Product Code: KWQ
• UDI-Device Identifier: 00887517200334
• UDI-Public: 00887517200334
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 03/23/2017

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: Physician
• Device Model Number: 8780417
• 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: 03/23/2017
• 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: Required Intervention
• Patient Age: 57 YR