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

Device Problem Break (1069)

Patient Problem Arthralgia (2355)

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

A dhr review could not be performed due to the lot number of the device not being identified.It is unknown how the system implant was damaged post-operatively.Post-operative implant malfunctions are listed as a possible adverse event related to implantation of the device in the system ifu.The system ifu potential adverse events section includes, ".The implant may loosen, deform, break, fatigue, or move, which may necessitate another surgery to correct the problem; and instruments also may break or malfunction in use, which may cause damage to the operative site or adjacent structures." it may be possible for the system implant to malfunction post-operatively if excessive force was applied to the device.The root cause of this complaint cannot be reliably determined.There has been one other complaint of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.

Event Description

The manufacturer was made aware of a device malfunction on 12/20/2023.It was reported that a patient came into the surgeon's office and presented with back pain.X-ray imaging confirmed a previously placed device had malfunctioned on the anterior portion of the device, for an index procedure performed (b)(6) 2012.It was reported the clinical course of action would be to remove the malfunctioned device and perform fusion if necessary, although no revision procedure has yet been scheduled.No additional information was able to be provided on the reported implant malfunction.

• 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: 18495255
• MDR Text Key: 333000980
• Report Number: 3005031160-2023-00028
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• 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: 80 YR