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

Model Number	725-090
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system rigid screw inserter showed an instrument with repeated use as identified by surface scratches and worn, but legible laser marking.The distal tip of the rigid screw inserter was fractured and missing as reported.A functionality assessment was not performed due to the damaged condition of the returned driver, which was removed from distributable inventory.A dhr review was performed for lot # 373146.It was found that the rigid screw inserter met specifications prior to being released to distributable inventory.The rigid screw inserter was released to distributable inventory on 07/29/2020, giving it an approximate age of 4 years.It may be possible for the distal tip of the system rigid screw inserter to be broken if excessive rotational force was applied, or if the screw inserter was shifted out of alignment while engaged with a system implant screw.The root cause of this complaint could not be reliably determined.The complaint investigation suggests the possibility that the screw inserter had excessive rotational force applied or was shifted out of alignment while engaged with an implant screw.There have been no complaints of similar nature in the past 12 months.Xtant will continue to monitor the field for complaints of the system rigid screw inserters that do not function as intended and will facilitate/perform complaint investigations as appropriate.
Event or Problem Description
The manufacturer was made aware of a product complaint on 04/15/2025.It was reported that a rigid screw inserter's tip broke while tightening a screw during surgery.An alternate available instrument was utilized to successfully complete the procedure.There were no known delays in procedure or patient complications associated with this complaint.A return authorization was issued for the return of the complaint instrument, which was received at the manufacturer for assessment on 04/18/2025.

• Brand Name: CERVALIGN ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln.; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 21980887
• Report Number: 3005031160-2025-00018
• Device Sequence Number: 8898711
• Product Code: KWQ
• UDI-Device Identifier: 00840311211135
• UDI-Public: 00840311211135
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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
• Device Model Number: 725-090
• Device Lot Number: 373146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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