MAUDE Adverse Event Report: Spinal Elements, Inc Vertu; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	P52412-708
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The acdf index surgery was performed circa 2018-2021 based on sales rep's historical sales knowledge and relationship with surgeon.A radiograph was taken on (b)(6) 2026 depicted the superior bone screw backed out of the stand alone cage.Revision surgery was perform on (b)(6) 2026 to remove the implant.
Additional Manufacturer Narrative
A radiograph taken on (b)(6) 2026 depicted the superior bone screw backed out of the stand alone cage.Dhr review concluded that the product was inspected and accepted for use and met all specified parameters of the quality inspection process (qip) with no associated nonconformance.Returned devices were visually and dimensionally inspected.The bone screws have no damage and still locked in place within the cage's retention rings.There was no failure of the screw's locking mechanism.The cage is torn apart, likely the result of removing the screw without unlocking the screw from the retention ring during explantation.Bone in-growth into the ti coating on the cage is not evident.The devices otherwise meet dimensional specifications, except the cage which cannot be measured due to damage.Unknown factors include: the exact date of the screw migration between follow-ups, patient activity at the time or prior to the event, the degree of spinal instability, or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma/fall was reported.) these factors could contribute to the stability and placement of the implant.Labeling review notes: "possible adverse effects".1.Early or late loosening of any or all of the components.2.Disassembly, bending, and/or breakage of any or all of the components.3.Loss of fixation (implant migration).

• Brand Name: Vertu
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): Spinal Elements, Inc; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive; suite 200; carlsbad, CA 92010 ; +1(760)607-1565
• MDR Report Key: 50671429
• Report Number: 3004893332-2026-00007
• Device Sequence Number: 15760170
• Product Code: OVE
• UDI-Device Identifier: 00840606110990
• UDI-Public: (01)00840606110990(10)191160(11)191105
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: P52412-708
• Device Lot Number: 191160
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• 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 Age: 48 YR
• Patient Sex: Male