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

Model Number	8780317
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no known malfunction of the nuvasive interbody implant or any information suggesting difficulty in initial placement of the construct.During the revision it was noted that the "locking mechanism was in the unlocked position".Available information suggests the cause may be related to use error.Product labeling indications: "potential risks identified with the use of this device system, which may require additional surgery include: device component fracture, loss of fixation, non-union, fracture of thh vertebra, and vascular or visceral injury".Warnings, cautions and precautions: to allow for proper utility of the locking mechanism during screw placement, use the self-centering awl to create a centered screw hole into the vertebral bodies.Device not returned.
Event or Problem Description
On (b)(6) 2016 a (b)(6) year old male was implanted at c4-c7 with an anterior cervical plate system.During a routine follow up visit it was determined that the left screw at c7 had backed out.On (b)(6) 2016 patient was revised.The surgeon removed and replaced the screws with the same length and added bone cement to the screw holes.There is no known malfunction of the nuvasive interbody implant or information suggesting difficulty in initial placement of the construct.

• 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: 5743377
• Report Number: 2031966-2016-00046
• Device Sequence Number: 13460531
• Product Code: KWQ
• UDI-Device Identifier: 00887517199898
• UDI-Public: 00887517199898
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

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: Physician
• Device Model Number: 8780317
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR