MAUDE Adverse Event Report: XTANT MEDICAL AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number X060-0080

Device Problem Material Fragmentation (1261)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

A visual assessment of the returned implant construct showed devices that had extensive surface scratches surrounding the plates.The crossbar insert was identified as damaged, with scratches present on the exposed end of the insert.The proximal opening of the threading on the locking plate was damaged and approximately half of the fractured set screw was present in the locking plate.The proximal portion of the locking plate set screw was fractured with some threading peeling away.Spikes on both the cross bar plate and locking plate were damaged and not sharp as intended.There was a rotational impact mark present on the cross bar and insert where the set screw was tightened to secure the implant construct.The placement of the set screw impact mark indicates the plates were not adequately compressed to allow for the set screw to sit on the flat portion of the cross bar prior to final tightening of the set screw.A functionality assessment was not performed because implants are intended for single use only, and explanted devices are discarded per procedure.A dhr review was performed for complaint lot# 11972 and there were no manufacturing anomalies identified.The device met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 11/19/2018.The system surgical technique guide step 3: implant insertion states, "once loaded, lower the instrument into the interspinous space and confirm placement via fluoroscopy." also, in the surgical technique guide, step 8: compression of plate states, "prior to applying compression, take a lateral x-ray to confirm proper positioning." the intraoperative management section of the system ifu provides guidance on confirming implant placement and states, "whenever possible or necessary, an imaging system should be utilized to facilitate surgery." the complaint details provided, and photos taken at the manufacturer were discussed with a subject matter expert to provide input on the reported implant malfunction.The assessment of the reported implant deficiency was that the system plates had not been compressed enough for the set screw to be tightened flat on the cross bar of the implant.If an interspinous plate construct was not adequately compressed, the cross bar would not be in the correct position for the set screw to be tightened flat.The rotational force applied to an uneven surface may allow the distal portion of the set screw to pull apart within the threading of the locking plate, and not identified until the set screw was being loosened to adjust implant position.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.

Event Description

The company was notified on 9/28/2021 of an implant malfunction that occurred after placing an interspinous plate construct.After implant placement, the physician elected to make a position adjustment of the implants.When the set screw of a locking plate assembly was being loosened, it sheared off.The implant construct was removed and successfully replaced with alternate implants without any further issues.There were no known patient complications associated with this complaint.The complaint device arrived at the manufacturer for assessment on 10/01/2021.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser lane; belgrade, MT 59714
• MDR Report Key: 12668531
• MDR Text Key: 277946224
• Report Number: 3005031160-2021-00022
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: M697X06000801
• UDI-Public: M697X06000801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X060-0080
• Device Lot Number: 11972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2018
• 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: 87 YR