MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC BULLET-TIP PEEK IBF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Model Number	30-P-INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system inserter showed signs of repeated use, as identified by surface scratches and worn laser markings.The inner draw rod was not present with the instrument and unable to be assessed.The handle assembly, as well as the four set screws at the bottom of the turning knob were noted loose.A functionality assessment was unable to be performed due to the damaged condition of the returned system inserter, which was removed from distributable inventory.The system inserter is intended to be used to place system implants.It was reported that while attempting to reposition an implant, the inserter was hit with a mallet and the inner rod of the inserter was damaged and detached from the inserter.A dhr review was performed for the lot and there was no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available since 01/18/2012, resulting in a lifespan of approximately 13 years.The root cause of the broken inserter was unable to be reliably determined, however it may be possible for the instrument to be broken if there was excessive force placed upon the inserter.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of damaged system inserters and will perform complaint investigations and regulatory reporting as appropriate.
Event or Problem Description
The manufacturer was made aware of a product complaint on 07/28/2025.It was reported that the inner rod of a system inserter was broken after being hit with a mallet to adjust the positioning of an implant cage.An alternate instrument was used to successfully complete the surgery.There was no delay in surgery and no known patient complications.A return authorization number was issued for return of the complaint inserter, which arrived at the manufacturer for assessment on 08/05/2025.

• Brand Name: BULLET-TIP PEEK IBF SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• 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: 22900215
• Report Number: 3005031160-2025-00028
• Device Sequence Number: 5986618
• Product Code: MAX
• UDI-Device Identifier: 00846468032081
• UDI-Public: 00846468032081
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K133455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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
• Operator of Device: Health Professional
• Device Model Number: 30-P-INSERTER
• Device Lot Number: 111985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown