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

Model Number 8787120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

No product was returned as product is still in-situ.A photograph of the locking mechanism provided was able to confirm the reported complaint.No patient injury was reported and no revision surgery is planned.Due to lack of information the root cause cannot be determined at this time.No additional investigation can be completed.Labeling review: "warnings, cautions and precautions.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." ".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." ".Bending of the nuvasive archon anterior cervical plate system is not recommended.Bending will compromise the mechanical performance of the plate and may adversely affect fit and function of the screw retaining mechanisms." ".Inspect the plate for damage after bending." "pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

Event Description

During a procedure the screw lock became detached from the plate when attempting to engage the mechanism.Due to the patient's patients bone quality and pathology replacement of the plate could not be performed.There is currently no plan to perform a revision surgery.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14151458
• MDR Text Key: 298879044
• Report Number: 2031966-2022-00079
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517208941
• UDI-Public: 887517208941
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8787120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose