MAUDE Adverse Event Report: XTANT MEDICAL HOLDINGS, INC. CORTERA SPINAL FIXATION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	150100-75050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual assessment of the returned complaint system implant screws showed both pedicle screw implants were fractured at an angle on the proximal end of the pedicle screw shank.There were also two system rods returned, one of which was bent more than the other.Lateral post-operative imaging from the index procedure and post-operative imaging from the revision procedure were provided by the complainant for review as part of the complaint investigation.A review of the index procedure post-operative imaging was unremarkable.The review identified a two-level posterior fixation construct from l4-s1.No interbody devices were visible in the disc space.No further assessment could be made using the image provided.Post-operative imaging from the revision procedure showed two fractured screws shanks at s1 and inclusion of l3 to the implant construct.Dhr reviews were performed for both device lots and there were no manufacturing anomalies identified.Both device lots met all required specifications prior to being released to distributable inventory.Part# 150100-75050, lot# ap22000142 has been available for distribution since 12/06/2022 and part# 150100-75055, lot# ap22000023 has been available for distribution since 7/19/2022.The surgical system ifu warnings/cautions/precautions section appropriately states "risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.", and "no spinal implant can withstand body loads for an indefinite period of time without the support of bone.In the event that successful fusion is not achieved, bending, breakage, loosening or disassembly of the device will occur." the root cause of this complaint cannot be reliably determined.There have been six other complaints of similar nature for post-operative pedicle screw malfunctions in the past 12 months.The manufacturer will continue to monitor reports for post-operative implant malfunctions.This report is associated with report# 3005031160-2024-00017.
Event or Problem Description
It was reported that, during a post-operative visit due to the onset of back pain at an adjacent level that was noted to be unrelated to the existing posterior fixation construct, it was identified that both pedicle screws at s1 had broken.A revision procedure was performed approximately one year after the initial implantation in which the malfunctioned screws were removed, and the remaining implant construct was extended to l3.The patient was reported to be in good health status with no additional procedures planned or required.An rma# was issued for return of the explanted devices, which were received at the manufacturer for assessment.

• Brand Name: CORTERA SPINAL FIXATION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW 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: 19455984
• Report Number: 3005031160-2024-00016
• Device Sequence Number: 20496318
• Product Code: NKB
• UDI-Device Identifier: 00810076563602
• UDI-Public: 00810076563602
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 150100-75050
• Device Lot Number: AP22000142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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: Hospitalization
• Patient Sex: Male