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

Model Number	66-345
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned cervical plate showed an implant with worn anodization and surface scratches.Two of the cervical plate screw locking mechanisms were fractured as reported.A functionality assessment was not performed due to the damaged condition of the returned implant, which was discarded per procedure for implants that have been implanted/explanted.A dhr review was performed for the implant complaint lot# and there were no manufacturing anomalies identified.The implant lot met all required specifications prior to being released to distributable inventory.The implant lot has been available for distribution since 5/02/2023.The screw locking mechanisms on the 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 may be possible for the screw locking mechanisms of a 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 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 four other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for similar complaints from the field.
Event or Problem Description
The manufacturer was made aware of a product complaint from a cervical plating system on 9/05/2023.It was reported that during a post-operative checkup for an index procedure in (b)(6) 2023, a system cervical plate was identified as malfunctioned.The complainant stated that the cervical plate locking mechanism failed and broke off so the screws backed out.A revision procedure was performed on (b)(6) 2023 with alternate products without any known patient complications.A return authorization was issued for return of the complaint implant, which was received at the manufacturer for assessment on 9/27/2023.

• 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: 17961373
• Report Number: 3005031160-2023-00017
• Device Sequence Number: 17463499
• Product Code: KWQ
• UDI-Device Identifier: 00846468087432
• UDI-Public: 00846468087432
• 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 Explanted 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): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66-345
• Device Lot Number: 435038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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 Sex: Unknown