MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. STREAMLINE OCT; DISTRACTOR

Model Number	26-DISTRACTOR-SM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 11/05/2025.The complainant reported that a system distractor had broken while being used in a posterior cervical surgery.The complainant stated that, "when put under load, the hinged joint can become a failure point.It was being used as intended, on the rod, b/w two screws." a more robust distractor from a different system was used to complete the surgery.There were not reported patient complications or delays as a result of the event.
Additional Manufacturer Narrative
A visual assessment of the device showed in instrument with repeated use as identified by minor surface blemishes and worn but legible laser markings.The distal left arm of the small distractor had been fractured from the device, and the retaining pin had fallen out of the space it once in was due to the fracture.The distal right distraction arm remained intact with the pin in place.A functional test was not completed for the instrument due to the damaged condition of the device, which was removed from distributable inventory.A dhr review was performed for lot#: 360802, and no manufacturing anomalies were identified.The system distractor lot met specifications prior to being released to distributable inventory.Lot#: 360802 has been available for distribution since 02/20/2020.The root cause of this complaint is exposure to extreme forces.The system distractor is routinely subjected to extreme forces and sterilization cycles.Extreme forces experienced during use and extreme temperature fluctuations from the sterilization process could possibly lead to the degradation of the materials used in the construction of the device over time, leading to an eventual fracture.There have been no other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor the field for system distractors that are reported as broken/worn out and will perform complaint investigations as appropriate.

• Brand Name: STREAMLINE OCT
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln.; belgrade MT 59714
• Manufacturer (Section G): XTANT MEDICAL HOLDINGS, INC.; 664 cruiser ln.; belgrade MT 59714
• Manufacturer Contact: rebecca lennemann ; 664 cruiser ln.; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 23697962
• Report Number: 3005031160-2025-00046
• Device Sequence Number: 21390202
• Product Code: HWN
• UDI-Device Identifier: 00840311237876
• UDI-Public: 00840311237876
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Device Model Number: 26-DISTRACTOR-SM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown