MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. IRIX-C CERVICAL INTEGRATED FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	T066-0300
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received and became aware of two unexpected malfunctioned system awls on 10/04/2022.There were no current communications or open complaint investigations for these returned instruments.Email communications were made with the complainant, who stated that the returned instruments had previously been addressed through the complaint management system.The manufacturer was unable to confirm that the instruments had been previously reported by the complainant.The complainant stated that the two system awls both malfunctioned during procedures and confirmed that neither malfunction resulted in any patient complications.No other information on the system awl malfunctions was available.A visual assessment of the returned system awls showed instruments with repeated use, as identified by worn laser markings and surface scratches.The distal tips of both awls were fractured and not returned.Functionality assessments were not performed due to the damaged condition of the system awls, which were removed from distributable inventory.A dhr review was performed for device lot# 866693 and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.Lot# 866693 has been available for distribution since 02/09/2016.The root cause of these instrument malfunctions cannot be reliably determined due to a lack of available information.The manufacturer is performing regulatory reporting diligence of malfunctioned instruments by submitting 3500a mdr forms for both instruments.While not associated with the same event, the returned instruments were received with a malfunctioned instrument from the same complaint source and reported under 3005031160-2022-00026.This report is also associated with report 3005031160-2022-00034, for the second additional instrument.
Event or Problem Description
The manufacturer received and became aware of two unexpected malfunctioned system awls on (b)(6) 2022.There were no current communications or open complaint investigations for these returned instruments.Email communications were made with the complainant, who stated that the returned instruments had previously been addressed through the complaint management system.The manufacturer was unable to confirm that the instruments had been previously reported by the complainant.The complainant stated that the two system awls both malfunctioned during procedures and confirmed that neither malfunction resulted in any patient complications.No other information on the system awl malfunctions was available.

• Brand Name: IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 15677731
• Report Number: 3005031160-2022-00033
• Device Sequence Number: 2303154
• Product Code: OVE
• UDI-Device Identifier: M697T06603001
• UDI-Public: M697T06603001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162944
• 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): 10/26/2022

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: T066-0300
• Device Lot Number: 866693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown