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

Model Number	66-DRIVER-SG
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system driver showed an instrument with repeated use, as identified by surface scratches and worn laser markings.The distal tip of the system driver was fractured as reported.A functionality assessment was not performed, due to the damaged condition of the returned system driver which was failed and removed from distributable inventory.A dhr review was performed for complaint lot# 335379 and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 2/14/2019.The distal tip of the system driver could be broken if excessive rotational force was applied, or if the driver was shifted out of alignment while engaged with a system screw.There have been two other complaints of similar nature for the system drivers with fractured distal tips.The manufacturer will continue to monitor for reports of non-functional system drivers and perform complaint investigations as appropriate.
Event or Problem Description
The manufacturer was made aware of a product complaint on 11/25/2024.It was reported that the distal tip of a system screwdriver was identified as having malfunctioned and was requested to be replaced.No additional information on the instrument deficiency was provided.An email inquiry was sent to the complaint source to best understand the condition of the returned complaint driver, and for regulatory assessment of the impact to the patient and/or procedure.An rma# was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 12/09/2024.

• 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 ; 4069245878
• MDR Report Key: 21049892
• Report Number: 3005031160-2024-00049
• Device Sequence Number: 15574267
• Product Code: KWQ
• UDI-Device Identifier: 00810076561899
• UDI-Public: 00810076561899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/31/2024

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-DRIVER-SG
• Device Lot Number: 335379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown