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

Model Number	8780215
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were x-rays provided to confirm the reported event.No product will be returned for evaluation as it remains in-situ.Potential adverse events and complications: ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).".".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.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.".Post-operative warnings: ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".Product remains in-situ.
Event or Problem Description
On (b)(6) 2017 patient underwent an anterior cervical discectomy and fusion at levels c4/5, c5/6 and c6/7.One month post-operative patient was informed two locking screws had back out at levels c4/5 and c6/7.No revision procedure has been planned.Patient will continue to be monitored.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7263742
• Report Number: 2031966-2018-00011
• Device Sequence Number: 16440290
• Product Code: KWQ
• UDI-Device Identifier: 00887517202338
• UDI-Public: 00887517202338
• Combination Product (Y/N): N
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/12/2018

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: Physician
• Device Model Number: 8780215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1