MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. AXLE INTERSPINOUS FUSION SYSTEM; SPINOUS PROCESS PLATE

Model Number X060-1520

Device Problem Material Fragmentation (1261)

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

Event Date 12/09/2022

Event Type  malfunction  

Event Description

The manufacturer was made aware of a product complaint on 12/20/2022.It was reported that the distal tip of a system inserter/compressor fractured during a surgical procedure.There were no known patient complications associated with this complaint, although there was a delay in treatment to address the instrument malfunction and utilize an alternate available instrument.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 12/27/2022.

Manufacturer Narrative

A visual assessment of the returned complaint inserter/compressor showed an instrument with minimal use, as identified by crisp laser markings and a lack of surface scratches.One distal end of the inserter/compressor was fractured as reported.A functionality assessment was not performed due to the damaged condition of the inserter/compressor which was removed from distributable inventory.A dhr review was performed for the device complaint 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 2/10/2021.The fractured distal tip of the inserter/compressor is attached to the body of the instrument with a pin that allows for minor movement to allow for implant placement in a various patient anatomy.It may be possible that application of excessive compression force may have contributed to the instrument malfunction.There have been two other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.

• Brand Name: AXLE INTERSPINOUS FUSION SYSTEM
• Type of Device: SPINOUS PROCESS 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: 16210520
• MDR Text Key: 309177978
• Report Number: 3005031160-2022-00046
• Device Sequence Number: 1
• Product Code: PEK
• UDI-Device Identifier: M697X06015201
• UDI-Public: M697X06015201
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2023

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: X060-1520
• Device Lot Number: 21179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 136 KG