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

Model Number	66-226
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review could not be performed due to the lot number of the device not being available.A system 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.It may be possible for a system cervical plate locking tab to not effectively retain the implant screw if it were fractured.The screw locking mechanisms on the system cervical plate are intended to retain the implant screws into patient bone after final placement.If the screw locking mechanisms were somehow fractured, it may be possible for the implant screws to back out of the intended position.It could be possible for the screw locking mechanisms of a system 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 system cervical plate.The root cause of this complaint cannot be reliably determined.There have been five other complaints of similar nature for this device in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.
Event or Problem Description
The manufacturer was made aware of a product complaint on 10/16/2023.It was reported that a system cervical plate was identified as having malfunctioned during a post-operative follow-up via x-ray.The x-ray image provided showed an inferior implant screw had backed out of the system cervical plate.The index procedure was performed on (b)(6) 2023 without any known complications.The complainant stated there was nothing negative they were aware of regarding the health status of the patient, and there was no revision procedure planned.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: 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: 18120093
• Report Number: 3005031160-2023-00019
• Device Sequence Number: 12638344
• Product Code: KWQ
• UDI-Device Identifier: 00810076561141
• UDI-Public: 00810076561141
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K211408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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: Health Professional
• Device Model Number: 66-226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female