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

Model Number	8787470
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-ray films provided to confirm the alleged event.Labeling: ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications known to occur include: damage to blood vessels." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s); neurological, vascular or visceral injury." ".To prevent improper screw placement, the trial drill guides must only be used to create pilot holes for the most superior holes of the archon anterior cervical plate.Only used the trial drill guides with the archon anterior cervical plate and variable screws." ".To prevent improper screw placement and hindrance of screw locking into the plate, the plate holding dual barreled dts guide must be used with the 2.5 x 13 mm dts archon drill.For proper trajectory, tighten the dts guide to the plate before drilling.Do not use the plate holding dual barreled dts guide with self-drilling screws alone or with an archon-r anterior cervical plate." no product returned.
Event or Problem Description
On (b)(6) 2018, patient underwent an anterior cervical discectomy and fusion procedure with no reported events.On (b)(6) 2018, patient was returned to the operating room due to a hematoma.During the procedure it was noticed the top locking mechanism on the plate was detached.
Event or Problem Description
Received xray films confirming the alleged even of back out.As per reporter hematoma did not cause an adverse event.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk boulevard; san diego 92121
• MDR Report Key: 8224858
• Report Number: 2031966-2019-00145
• Device Sequence Number: 18886586
• Product Code: KWQ
• UDI-Device Identifier: 00887517205902
• UDI-Public: 887517205902
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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?: Yes
• Operator of Device: No Information
• Device Model Number: 8787470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 04/13/2019
• 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: Hospitalization