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

Device Problem Migration (4003)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

X-ray images of the reported implant deficiency were provided, which appeared to show an inferior implant screw had migrated beyond the surface of the system cervical plate.The part and lot number of the migrated implant screw were not available, and a request was made that upon completion of the revision procedure that implants be identified.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 five other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for complaints of migrated implants.

Event Description

The manufacturer was made aware of a product complaint on 2/14/2024.It was reported that during a follow-up visit on (b)(6) 2024 imaging of a two-level cervical plate showed an implant screw had migrated from its intended position.The index two-level acdf procedure was performed on (b)(6) 2023, and the first post-surgical follow-up occurred on (b)(6) 2023 without identification of any implant deficiency.There were no known incidents between the (b)(6) 2024 follow-ups that may have contributed to the implant deficiency.The surgeon intends to perform a revision procedure to address the implant deficiency, which as of (b)(6) 2024 has not yet been scheduled.If additional relevant information on the migrated system screw is received, a follow-up report will be submitted as appropriate.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: ANTERIOR CERVICAL 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: 18887643
• MDR Text Key: 337559779
• Report Number: 3005031160-2024-00005
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 02/14/2024
• 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