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

Model Number UQI00008

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The manufacturer was made aware of a medical device implant that was implanted after the expiration date identified on the product package.There were no known patient complications or delay in treatment associated with this complaint.The complainant and surgical facility inquired about the possibility of expiration date extension of the implanted device, which was not supported by the packaging validation.

Manufacturer Narrative

The surgical procedure was performed on 10/18/2023, and the expiration date identified on the product package was 5/31/2023.The complainant stated that an alternate sales representative was covering for the procedure at the surgical facility and brought implants already in their possession for the procedure.The manufacturer sends routine communications to sales staff and distributors to inform them of nearing or surpassed expiration dates of consigned sterile packed items in their respective sales area.The expiring field inventory notification was sent to the sales representative that was covering the surgical procedure on (b)(6) 2023, which included identification of the medical device implant and expiration date.The medical device implants identified on the expiring field inventory notification sent to the sales representative were not returned to the manufacturer for final disposition.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for reports of medical device implants utilized passed the documented expiration date.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• 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: 18142095
• MDR Text Key: 328377048
• Report Number: 3005031160-2023-00021
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 04260148898501
• UDI-Public: 04260148898501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2023

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 Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: UQI00008
• Device Lot Number: 2418311011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female