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

Model Number	26-INSITUBEND-R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware of a product complaint on 2/25/2025.It was reported that during a posterior cervical fusion procedure a rod bender was broken while attempting to bend a rod in-situ.There were no known patient complications or delay in treatment associated with this complaint.The physician was able to use another instrument to successfully complete the procedure.The complaint instrument was discarded at the healthcare facility.No additional information available.
Additional Manufacturer Narrative
A visual assessment of the complaint instrument was unable to be physically performed as the instrument was discarded at the hospital facility.Photographs of the complaint instrument showed an instrument with repeated use as identified by surface scratches and the distal working end of the instrument was broken off as reported.The root cause of this complaint was unable to be reliably determined, however may be related to excessive force being applied to the instrument.A dhr review was performed for the instrument lot and there were no manufacturing anomalies identified.The instrument lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 07/02/2019, resulting in a lifespan of approximately 6 years.There has been zero other complaints of similar nature for the implant in the past 12 months.The manufacturer will continue to monitor for reports regarding broken rod benders and perform complaint investigations as appropriate.

• Brand Name: STREAMLINE OCT
• Common Device Name: BENDER
• 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 lane; belgrade, MT 59714 ; 4069245878
• MDR Report Key: 21688974
• Report Number: 3005031160-2025-00007
• Device Sequence Number: 9308510
• Product Code: HXW
• UDI-Device Identifier: 00840311238699
• UDI-Public: 00840311238699
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/25/2025

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: 26-INSITUBEND-R
• Device Lot Number: 346043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2019
• 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