MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC COFLEX INTERLAMINAR TECHNOLOGY; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	UQI00008
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device product labeling adequately displays the expiration date assigned to the device on the packaging.The ifu associated with the device states, "both inner and out packaging, including seals, should be thoroughly inspected prior to implantation." medical device expiration date management by the distributor and the surgical facility contributed to this product complaint.There have been zero other complaints of similar nature for a device from this product line being implanted beyond expiration in the past 12 months.The manufacturer will continue to monitor the field for reports of implants utilized beyond the documented expiration date.
Event or Problem Description
The manufacturer was made aware of a medical device that was utilized beyond the expiration date identified on the product packaging on 05/27/2025.A product usage form was submitted to the manufacturer which identified a medical device lot that had surpassed the expiration date.The medical device had a documented expiration date of 06/10/2024 and was implanted on (b)(6) 2024.There were no known patient complications or delay associated with this product complaint.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• 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: 22332608
• Report Number: 3005031160-2025-00020
• Device Sequence Number: 9069666
• Product Code: NQO
• UDI-Device Identifier: 04260148898501
• UDI-Public: 04260148898501
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: 06/10/2024
• Device Model Number: UQI00008
• Device Lot Number: 2418312973
• 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: 05/27/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2014
• 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: 75 YR
• Patient Sex: Male