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

Model Number	8787134
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned explants and associated radiographs suggests inappropriate contact between components during implantation resulting in lock fatigue and subsequent screw back out.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s) loss of fixation" ".All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".All components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.To prevent thread stripping, caution should be taken not to over-tighten the standard temporary tack once it has tightened against the plate.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.Do not use self-centering awls without a drill guide.For freehand screw insertion where an awl is desired, use of the self-centering awl is required at all times to avoid incomplete or improper locking.".
Event or Problem Description
On (b)(6) 2016 a patient underwent an anterior cervical discectomy fusion at c5 level with no reported issues.At a later date radiographs showed inferior screw at c5 level backed out.On (b)(6) 2017 a revision procedure took place replacing the plate and screws.

• 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: 6978365
• Report Number: 2031966-2017-00152
• Device Sequence Number: 19199824
• Product Code: KWQ
• UDI-Device Identifier: 00887517208989
• UDI-Public: 00887517208989
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 8787134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1