MAUDE Adverse Event Report: NANOVIS SPINE LLC CAPSTONE NANOPEEK; ADAPTIX PEEK INTERBODY WITH NANOTECHNOLOGY

Model Number	74332410
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempted contact with initial reporter (b)(6) 2026 4:42pm called (b)(6) - per information provided from the medtronic product event summary report attempted contact with initial reporter (b)(6) 2026 11:29am called (b)(6) - followed voice prompts to "records" and left a voice message initial review of product event summary (b)(4) determined the adverse event was not "caused" by the implant.The implant is intended to be used with supplemental fixation.The supplemental fixation of 2 medtronic bone screws were loosened and backed out.Contacted medtronic rep.And post-operative trauma is unknown, bone quality measures before initial implant were unknown, and the same surgeon performed implant and explant.Investigation details:the adaptix¿ peek interbody system with nanotechnology devices and the capstone control¿ peek spinal system with nanotechnology devices including those with macro-, micro- and nano-roughened surface textured features are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from l2-s1.These patients should have had six months of nonoperative treatment.These patients may have had a previous non-fusion spinal surgery and/or may have up to grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s).Additionally, adaptix¿ peek interbody system with nanotechnology and the capstone control¿ peek spinal system with nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.The adaptix¿ peek and the capstone control¿ peek devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate.These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.
Event or Problem Description
Information provided from medtronic product event summary report (b)(4) received on (b)(6) 2026: (b)(6) 2026 (b)(6) (rep, hcp): information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having transforaminal lumbar interbody fusion spinal therapy at l3/4 and l4/5.It was reported that the implant backed out at the l4/5 level.There was a lack of solid fusion at the affected level.The patient was scheduled for additional surgery to remove the implant at a later date.It was unknown if there were any patient symptoms or complications as a result of the event.(b)(6) 2026 (rep): additional information received from the manufacturing representative that the revision surgery performed on (b)(6) 2026.Patient had lingering back pain post operatively.Patient had a pre-operative diagnosis of lumbar radiculopathy needing a l3-l5 fusion.(b)(6) 2026 (rep): additional information received from the manufacturing representative that the 2 screws were loosened and they were explanted on the revision surgery performed on (b)(6) 2026.

• Brand Name: CAPSTONE NANOPEEK
• Common Device Name: ADAPTIX PEEK INTERBODY WITH NANOTECHNOLOGY
• Manufacturer (Section D): NANOVIS SPINE LLC; 5865 e state road 14; columbia city IN 46725
• Manufacturer (Section G): NANOVIS SPINE LLC; 5865 e state road 14; columbia city IN 46725
• Manufacturer Contact: tabitha lundblad ; 5865 e state road 14; columbia city, IN 46725 ; 8779076266
• MDR Report Key: 24713248
• Report Number: 3009446038-2026-00001
• Device Sequence Number: 12194072
• Product Code: MAX
• UDI-Device Identifier: 00814216028280
• UDI-Public: 00814216028280
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K241605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74332410
• Device Catalogue Number: 74332410
• Device Lot Number: MI179986
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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: Required Intervention
• Patient Sex: Unknown