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

Model Number UQI00012

Device Problem Material Fragmentation (1261)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that one of the superior wings of a system implant fractured during the final crimping process.There were no known patient complications associated with this complaint.An alternate available system implant was successfully implanted without incident.

Manufacturer Narrative

A dhr review was performed for the complaint device lot, and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/11/2020.The system surgical technique guide provides guidance on appropriate use of the bending pliers and crimping pliers to prepare and place system implants.The surgical technique guide step states the crimping plier should be inserted into implant device's wings and gentle pressure should be applied to the handles of the crimping pliers such that the implant device's wings crimp around the spinous process.The complainant reported that both the bending pliers and crimping pliers were utilized during the procedure for the respective steps in which the instruments are used to prepare the system implant for placement.It was also reported that the crimping pliers were not engaging properly on the superior process wing during the placement and crimping process.It may be possible that improperly engaged crimping pliers may have contributed to the reported implant malfunction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for implant malfunctions from the field.

• 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
• MDR Report Key: 18243652
• MDR Text Key: 329448736
• Report Number: 3005031160-2023-00022
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 04260148898525
• UDI-Public: 04260148898525
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2023

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 Model Number: UQI00012
• Device Lot Number: 2420360973
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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