MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. COFIX SSYTEM; SPINOUS PROCESS PLATE

Model Number	RQI00010
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspections were not performed due to the implant fixation screw not being available for inspection.A dhr review was not performed due to manufacturing records not being available to review as part of the complaint investigation.The risk analysis fmea was reviewed which included "broken or damaged screw or sleeve during implantation", with "misalignment of screw ans [sic] sleeve during tightening" as a potential cause of hazard.The risk was mitigated by designing a special lateral screw inserter, and the risk/benefit ratio was recorded as "remaining risk is acceptable when weighted against the benefits." it may be possible for a system fixation screw to break if excessive rotational force was applied while tightening, or if there was misalignment of the screw and sleeve during tightening.It could be possible to apply excessive rotational force to the system fixation screw if the screw and sleeve were rotated beyond what is required to secure the implant in its final location.Misalignment of the screw and sleeve could allow for cross-threading when engaged and tightened.A cross-threaded screw and sleeve may seize, and additional force applied may result in the reported implant malfunction.Correct alignment of the screw and sleeve of the fixation screw must be achieved for appropriate engagement.A special lateral screw inserter was designed to aid in appropriate alignment of the screw and sleeve prior to engagement and rotation.The root cause of this complaint cannot be reliably determined.There have not been any other complaints of similar nature in the past 12 months.The manufacturer will continue to monitor this product family for complaints from the field.
Event or Problem Description
The manufacturer was made aware of a product complaint on (b)(6) 2023.It was reported that a fixation screw from a system implant fractured while being final tightened for implant placement.There were no known patient complications or delay in treatment associated with this complaint.An alternate available fixation screw was used to successfully complete the surgical procedure.

• Brand Name: COFIX SSYTEM
• Common Device Name: SPINOUS PROCESS PLATE
• 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: 17961975
• Report Number: 3005031160-2023-00018
• Device Sequence Number: 6565216
• Product Code: PEK
• UDI-Device Identifier: 04260148898242
• UDI-Public: 04260148898242
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201704
• 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): 10/12/2023

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: RQI00010
• Device Lot Number: 2021001856
• 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: 09/12/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female