MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CONTACT ANTERIOR LUMBAR PLATE SYSTEM; INSERTER

Model Number	25-INSERTER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inserter was returned to the manufacturer for evaluation and the reported event was confirmed.The instrument had signs of wear such as minor nicks and surface blemishes.One of the distal prongs of the inserter was missing as reported.Operative notes and medical records were not provided for review of the usage/technique.A review of the manufacturing records for this lot was performed and no manufacturing anomalies were identified.The instrument met all required specifications prior to being released to distributable inventory on 03/05/2021, giving the device an approximate field life of four years.The root cause of this complaint cannot be reliably determined; however, it is possible that the inserter was not fully seated on the screw, leading excessive force to be applied to one of the grasping arms, causing it to fracture from the rest of the device.It is unknown how many times the instrument has been used in the field.There has been one other complaint of similar nature for the system inserter in the past 12 months.The manufacturer will continue to monitor the field for reports of non-functional instruments and will perform complaint investigations as appropriate.
Event or Problem Description
It was reported that a distal grasping arm of the system inserter broke during a procedure.The broken grasping arm was removed from the patient via suction.There were no know patient complications associated with this complaint and the surgical procedure was completed with minimal delays.No additional information is available.

• Brand Name: CONTACT ANTERIOR LUMBAR PLATE SYSTEM
• Common Device Name: INSERTER
• 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 59414 ; 4065793168
• MDR Report Key: 22772409
• Report Number: 3005031160-2025-00027
• Device Sequence Number: 9487976
• Product Code: LXH
• UDI-Device Identifier: 00840311232857
• UDI-Public: 00840311232857
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/11/2025

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: 25-INSERTER
• Device Lot Number: 391141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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