MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM; ANTERIOR CERVIAL PLATE SYSTEM

Device Problem Migration (4003)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

The manufacturer was made aware of a product complaint on 3/04/2024.It was reported that during a follow-up visit on (b)(6) 2023 imaging of an unknown four-level cervical plate showed an implant screw had backed out from its intended position.The index acdf procedure was performed on (b)(6) 2023.An x-ray image was provided which appeared to show an inferior implant screw had backed out from its intended position.The x-ray image identified additional posterior stabilizing interbody devices.There is no current plan to revise the patient.

Manufacturer Narrative

The part and lot number of the backed-out implant screw were not available.A dhr review could not be performed due to the lot number of the device not being available.The system ifu appropriately lists "implant failure" as a possible adverse effect related to implantation of the surgical system.A cervical plate implant screw may back out of the intended location if the locking tab of the cervical plate did not effectively retain the implant screw.The screw locking mechanism of the cervical plate are intended to retain the implant screw into patient bone after final placement.If the screw locking mechanism was somehow fractured, it may be possible for the implant screw to back out of the intended position.It could be possible for the screw locking mechanism of the cervical plate to fracture if excessive force was present between the implant screw and locking mechanism interface.Excessive force at the interface may be possible if the implant screw was angled outside of recommendation or not fully seated within the cervical plate.The root cause of this complaint cannot be reliably determined.There have been six other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for complaints of backed out implant screws.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: ANTERIOR CERVIAL PLATE SYSTEM
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 19008749
• MDR Text Key: 339331094
• Report Number: 3005031160-2024-00007
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other