MAUDE Adverse Event Report: XTANT MEDICAL SILEX SACROILIAC JOINT FUSION SYSTEM; SACROILIAC JOINT FIXATION/SACROILIAC JOINT FUSION

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Implant Pain (4561)

Event Date 06/23/2021

Event Type  Injury  

Manufacturer Narrative

A dhr review could not be performed due to the device part and lot number not being available.A phone call with the vp of marketing, director of hardware engineering, and the marketing product manager was made on 6/30/2021 to discuss the system removal complaint and possible solutions for a successful implant removal.The complainant reported that the difficulty removing the implant was due to bone growth that had penetrated the fenestrations in the implant, resulting in increased resistance when attempting to remove the implant.Possible solutions were discussed to remove bony ingrowth both within the implant and surrounding the proximal end of the implant, which would reduce the force required to remove the implant.The surgical system is intended to promote bone growth and fusion.Per the system product guide, the design of the implant allows for bone graft to be introduced into the joint and implant in order to promote fusion.The surgical system is a true bony fusion and arthrodesis system.The implant and instrumentation suite allows for direct exposure and preparation of the si joint surface, placement of bone graft into the si joint space under direct visualization, and placement of bone graft directly with the system implant itself.There have not been any other complaints of similar nature in the past 12 months.The company will continue to monitor this device for complaints from the field.Continuous attempts to gather complaint incident information have been made, and a follow-up report will be submitted if/when there is additional information available regarding the scheduled revision procedure and patient health status.This report is associated with 3005031160-2021-00013.

Event Description

The company received notification on 6/28/2021 of an implant removal instrument malfunction that occurred during a scheduled removal/revision procedure.The revision procedure was being performed due to insufficient implant placement during the original (b)(6) 2020 procedure.The system implant was pressing on the patient's s1 nerve root, presenting pain and partial nerve loss.The removal procedure was unsuccessful, approximately 30-minutes was spent recovering the broken instrument components.A return authorization label was issued for return of the surgical tray that contained the complaint instrument, which arrived at the company for complaint assessment on 6/25/2021.

Event Description

On (b)(6) 2021 a conference call with the complainant, manufacturer product manager, and regulatory affairs associate was made to discuss patient status, techniques for a successfull removal/revision, and scheduling of the additional surgical procedure.An additional physician was consulted on the case and has a plan for successful removal/revision of the device.The complainant did not know when the removal preocedure would be scheduled and indicated that elective surgeries in their area have been put on hold due to the covid-19 pandemic.The patient is in good health status, it is unknown when the revision surgery will occur.The manufacturer is submitting this follow-up mdr.This follow-up report is associated with mfr 3005031160-2021-00014.

• Brand Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Type of Device: SACROILIAC JOINT FIXATION/SACROILIAC JOINT FUSION
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 12236196
• MDR Text Key: 263818544
• Report Number: 3005031160-2021-00014
• Device Sequence Number: 1
• Product Code: OUR
• Combination Product (y/n): N
• PMA/PMN Number: K140079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR