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

Catalog Number	11-6401
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately six months post-operatively patient reported pain following a patient fall approximately 3 months post-operatively; on radiograph, one locking screw was observed to be disengaged from a pedicle screw in the pedicle screw construct.A procedure was performed to remove and replace the subject device.

• Brand Name: SALVO® SPINE 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: 22560860
• Report Number: 3004638600-2025-00003
• Device Sequence Number: 9566322
• Product Code: NKB
• UDI-Device Identifier: 10840642163704
• UDI-Public: 10840642163704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 06/28/2025

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: 11-6401
• Device Lot Number: 662Z083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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