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

Catalog Number	11-6400
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During post-operative radiographic imaging a pedicle screw yoke was observed to be un-engaged to the screw shank.A surgical procedure was performed on (b)(6) 2023 to remove and replace the hardware.
Additional Manufacturer Narrative
The pedicle screw construct removed was returned for evaluation.Evaluation did not find any device issues related to this event.The exact cause could not be determined.Review of production and inspection records did not identify any issues relevant to this event.
Additional Manufacturer Narrative
D4: correction to primary unique device identifier.

• 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 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 18449964
• Report Number: 3004638600-2024-00001
• Device Sequence Number: 20589026
• Product Code: NKB
• UDI-Device Identifier: 10840642163711
• UDI-Public: 10840642163711
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 11-6400
• Device Lot Number: 663Y081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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