MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM; POSTERIOR OCCIPITO-CERVICO-THORACIC SYSTEM

Model Number	26-R2R-XLINK-DRVR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional assessments were unable to be performed due to the devices not being returned to the manufacturer, nor were photographs provided.It was reported that the system drivers became damaged after being used to remove instrumentation that had been implanted three years prior.The set screws of the instrumentation were reported to not budge, resulting in the driver to break.A review of manufacturing records for this driver lot was performed with no manufacturing anomalies identified.The driver lot met all required specification prior to being released to distributable inventory on 02/05/2014, resulting in an approximate lifespan of eleven years.A definitive root cause was unable to be determined with the information provided; however, the driver damage may be related to excessive force applied to the instrument in attempt to remove instrumentation.There have not been any other complaints of similar nature in the past twelve months.The manufacturer will continue to monitor for reports of damaged system drivers and will perform complaint investigations and regulatory reporting as necessary.Report 1 of 2.
Event or Problem Description
The manufacturer was made aware of a product complaint on 08/15/2025.It was reported that two drivers were damaged after being used to remove instrumentation that was implanted three years ago.It was confirmed that this instrument removal was normal course of treatment for the patient.Alternate removal tools were used to successfully complete the surgery.There was no delay in surgery and no known patient complications.A return authorization number was issued for the return of the complaint drivers, however they were not returned to the manufacturer after multiple attempts.

• Brand Name: STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
• Common Device Name: POSTERIOR OCCIPITO-CERVICO-THORACIC SYSTEM
• 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: 23039540
• Report Number: 3005031160-2025-00030
• Device Sequence Number: 15821924
• Product Code: KWP
• UDI-Device Identifier: 00846468054601
• UDI-Public: 00846468054601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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-R2R-XLINK-DRVR
• Device Lot Number: 172608
• 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: 08/15/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2014
• 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