MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CONTACT ALP; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	25-TIGHTENER
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 8/11/2025.It was reported that one of the distal engagement tips of the system screw tightener broke off when being utilized during a surgical procedure.There were no known patient complications with this instrument malfunction, the surgical procedure was successfully completed without further incident.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer for assessment on 8/21/2025.
Additional Manufacturer Narrative
A visual assessment of the returned system screw tightener showed an instrument with repeated use, as identified by worn laser markings and surface scratches.One of the four distal engagement tips was broken and not present as reported.The three remaining engagement tips were bent in a manner that suggests the instrument was being rotated clockwise when the damage occurred.A functionality assessment was not performed due to the damaged condition of the returned instrument, which was removed from distributable inventory.A dhr review was performed for lot# 391921 and there was no manufacturing deficiencies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 5/27/2021.It may be possible for one of the distal engagement tips of the screw tightener to break while being used in a surgical procedure if excessive force was placed on the tip.If the screw tightener was not fully engaged with the system screw, it can cause increased pressure to the engaged portion of the engagement tips and may contribute to the observed instrument malfunction.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor for reports of broken instruments and perform complaint investigations and regulatory reporting as appropriate.

• Brand Name: CONTACT ALP
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 ; 4069245878
• MDR Report Key: 22992505
• Report Number: 3005031160-2025-00029
• Device Sequence Number: 9089811
• Product Code: KWQ
• UDI-Device Identifier: 00840311233175
• UDI-Public: 00840311233175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 25-TIGHTENER
• Device Lot Number: 391921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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