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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a system driver was broken while being used in a surgical procedure.There were no known patient complications or delay in treatment associated with this complaint.The complainant provided a photo that identified the instrument udi but did not show the broken portion of the system driver.It is unclear if the instrument torx tip or distal sleeve was broken.An rma# was issued for return of the complaint instrument, which was not received at the manufacturer for assessment.
Additional Manufacturer Narrative
A visual assessment of the photo provided showed an instrument with repeated use, as identified by worn laser markings and surface scratches.The reported instrument deficiency could not be confirmed with the image provided.A functionality assessment could not be performed due to the instrument not being received at the manufacturer for complaint assessment.A dhr review was performed for lot# 354398 and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.The instrument has been available for distribution since 11/22/2019.It may be possible for the tip of a system driver to break while being used if excessive torque was applied or if the instrument was shifted out of alignment while engaged with the head of a system screw.If the patient had very dense bone or if it was not effectively prepared for screw implant placement, it may be possible for the tip of the driver to break due to excessive torque applied.If the driver is engaged with a system screw and not pulled straight up and away as identified in the system surgical technique guide, it may be possible for the tip to break from the instrument.The root cause of this complaint cannot be reliably determined.There have been 6 other complaints of similar nature for system drivers with broken distal tips in the past 12 months.The manufacturer will continue to monitor reports of broken system drivers.

• 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: 19455980
• Report Number: 3005031160-2024-00013
• Device Sequence Number: 6652417
• Product Code: KWQ
• UDI-Device Identifier: 00846468088088
• UDI-Public: 00846468088088
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 354398
• 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: 05/06/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2019
• 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