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

Model Number	T080-0042
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual assessment of the returned system implant inserter showed an instrument with repeated use, as identified by surface scratches, worn laser markings, corrosion, and implant inserter tip engagement wear marks.The implant inserter drawbar was fractured proximal to the boss that engages with the implant inserter tip.A functionality assessment was not performed due to the damaged condition of the implant inserter, which was removed from distributable inventory.A dhr review was performed for complaint lot#: 045211 and there were no manufacturing anomalies identified.The device lot met all required specifications prior to being released to distributable inventory.This lot has been available for distribution since 1/28/2016.The damaged drawbar of the implant inserter prevents it from functioning as intended for implant inserter tip engagement.It is unknown how the drawbar of the implant inserter was damaged.It may be possible that excessive force placed on the implant inserter drawbar could have contributed to the instrument malfunction.It could also be possible that an implant inserter tip may have got stuck in the implant inserter at some point, and in an attempt to remove the inserter tip, the drawbar could have been damaged.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this instrument for complaints from the field.
Event or Problem Description
The manufacturer was made aware of an instrument malfunction on 11/15/2022.It was reported that a system implant inserter malfunctioned during a surgical procedure after being impacted for implant placement and was requested to be replaced.The fractured portion of the implant inserter was recovered and there were no known patient complications associated with this complaint.An alternative available implant inserter was used to successfully complete the procedure.A return authorization was issued for return of the complaint instrument, which was received at the manufacturer on 11/17/2022 for assessment.

• Brand Name: IRIX-A LUMBAR 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: 15978367
• Report Number: 3005031160-2022-00039
• Device Sequence Number: 12511883
• Product Code: OVD
• UDI-Device Identifier: M697T08000420
• UDI-Public: M697T08000421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171567
• 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): 12/14/2022

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: T080-0042
• Device Lot Number: 045211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2016
• 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 Age: 47 YR
• Patient Sex: Male