MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC INTICE-C POROUS TI CERVICAL INTERBODY SYSTEM; Intervertebral fusion device with bone graft, cervical

Model Number	X098-0206-STR
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the actual implant was unable to be performed as the implant was discarded at the hospital facility.An assessment of an implant from the same lot that was retained by the manufacturer was performed.The implant was measured with a calibrated caliper at the manufacturing facility, which confirmed that the implant was the appropriate measurement listed on the packaging.Communication with the complainant confirmed that the measurement taken at the hospital was performed with a ruler, which may result in an inaccurate measurement.A dhr review was performed for the implant lot and there were no manufacturing anomalies identified.The dhr review confirmed that the contract manufacturer performed 100% inspection and measurement on this lot.The implant lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since (b)(6) 2021.The reported problem was unable to be reproduced during the investigation.There has been zero other complaints of similar nature for the implant in the past 12 months.The manufacturer will continue to monitor for reports regarding implants and perform complaint investigations as appropriate.
Event or Problem Description
The manufacturer was made aware of this product complaint on (b)(6) 2025.It was reported that while performing a 3 level anterior cervical discectomy and fusion, the surgeon believed the implant that was used may have been mislabeled as the incorrect size.The implant was labeled as 6mm, however the complainant assessed the implant as 5mm.There were no known patient complications associated with this complaint, however there was a slight delay to allow the surgeon to remove and replace the implant.The implant was disposed of at the healthcare facility.No additional information available.

• Brand Name: INTICE-C POROUS TI CERVICAL INTERBODY SYSTEM
• Common Device Name: Intervertebral fusion device with bone graft, cervical
• 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 lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 21415439
• Report Number: 3005031160-2025-00004
• Device Sequence Number: 9327993
• Product Code: ODP
• UDI-Device Identifier: M697X0980206STR1
• UDI-Public: M697X0980206STR1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/20/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2026
• Device Model Number: X098-0206-STR
• Device Lot Number: 062021FG03052104
• 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: 01/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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
• Patient Age: 52 YR
• Patient Sex: Unknown