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

Model Number UQI00010

Device Problem Expiration Date Error (2528)

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

Event Date 01/04/2024

Event Type  malfunction  

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 has been one other complaint 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 Description

The manufacturer was made aware of a medical device that was utilized beyond the expiration date identified on the product packaging on 1/12/2024.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 5/31/2023 and was implanted on (b)(6) 2024.There were no known patient complications or delay associated with this product complaint.Additional attempts to collect relevant complaint incident details from the complainant were unsuccessful.

• 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: 18681980
• MDR Text Key: 336228171
• Report Number: 3005031160-2024-00001
• Device Sequence Number: 1
• Product Code: NQO
• 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: 02/09/2024

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: UQI00010
• Device Lot Number: 2418313005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 41 YR
• Patient Sex: Male