MAUDE Adverse Event Report: SPINE WAVE, INC. ANNEX® ADJACENT LEVEL SYSTEM; THORACOLUMBAR PEDICLE SCREW SYSTEM

Catalog Number	11-5052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately three months post-operatively following a procedure to extend an existing pedicle screw construct, a patient reported pain.On radiograph, the rod connectors were observed to be disengaged from the rods in the pedicle screw construct.A procedure was performed to remove and replace the subject device.
Additional Manufacturer Narrative
The hospital has reported that the devices will not be returned.

• Brand Name: ANNEX® ADJACENT LEVEL SYSTEM
• Common Device Name: THORACOLUMBAR PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise dr.; suite 210; shelton CT 06518
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 24485047
• Report Number: 3004638600-2026-00003
• Device Sequence Number: 5104538
• Product Code: MNH
• UDI-Device Identifier: 10840642102758
• UDI-Public: 10840642102758
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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 Catalogue Number: 11-5052
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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