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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

The manufacturer was made aware of a product complaint on 11/17/2023.It was reported that a surgeon was attempting a two-level case and one of the implants broke.The surgeon was able to place one device and did not place the second device.No other information on the reported implant malfunction was provided, and repeated attempts to collect relevant complaint incident information via emails and phone call were unsuccessful.It is unknown how the complaint implant was damaged, and how the surgeon addressed the second surgical level.If additional information is provided on the patient health status or identification of the complaint device, a follow-up report will be submitted.

• 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: 18339235
• MDR Text Key: 330677209
• Report Number: 3005031160-2023-00024
• 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: 12/17/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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