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

Model Number	X080-5530SD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fractured implant screw was not available to be returned to the company due to being discarded at the surgical facility.The implant system surgical technique guide provides guidance on appropriate screw insertion and angulation.Implant screws are intended to be placed at the intended 35° and driven until the implant screw passes the locking arm on the spacer faceplate.The physician was unable to place the implant screw at the proper angle, which prevented the locking arm of the spacer from securing the implant screw.A cautionary statement in the surgical technique guide states, "over-angulation of the screw beyond 3 degrees in any direction may result in failure of the screw to engage the implant and/or locking arm." the complainant reported the physician was unable to orient the implant screw at the intended 35° angle, and over torqued the driver which caused the implant screw malfunction.It was reported that the inability to place the implant screw at the proper angle was due to subpar l5-s1 exposure and patient anatomy.The physician indicated that the implant screw malfunction did not compromise the surgery or patient in any way due to posterior fixation in place from a previous surgical procedure.There is a cautionary statement included in the surgical technique guide that states, "installing fewer than three screws will significantly reduce the implant fixation and increase the risk of implant failure." there have not been any other complaints of similar nature in the past 12 months.The company will continue to monitor this product family for complaints from the field.
Event or Problem Description
The company received notification on (b)(6) 2021 regarding a system screw that fractured while being tightened during a l5-s1 fusion procedure.The fractured screw was not replaced, and the distal portion of the fractured screw was not recovered.There were no known patient complications associated with this complaint.

• Brand Name: IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XTANT MEDICAL; 664 cruiser lane; belgrade MT 59714
• MDR Report Key: 11408152
• Report Number: 3005031160-2021-00002
• Device Sequence Number: 4275042
• Product Code: OVD
• UDI-Device Identifier: M697X0805530SD1
• UDI-Public: M697X0805530SD1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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: X080-5530SD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR