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

Model Number	8687240
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation as product was retained by the hospital facility.No xray films were provided to confirm the alleged event.Labeling review: potential adverse events and complications: ".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 archon anterior cervical plate system is designed to assist in providing 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.Patients should be fully informed of the risk of implant failure.".
Event or Problem Description
On (b)(6) 2018 during a post-op visit, it was determined that one of the plate screws at the c6-7 level had backed out.A revision procedure was performed on (b)(6) 2018 where the nuvasive hardware was removed and posterior cervical fusion was performed.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FXATION ORTHOSIS
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7787375
• Report Number: 2031966-2018-00129
• Device Sequence Number: 19345262
• Product Code: KWQ
• UDI-Device Identifier: 00887517221667
• UDI-Public: 00887517221667
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: Health Professional
• Device Model Number: 8687240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR