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	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During routine post-operative radiographic imaging, a pedicle screw yoke was observed to be un-engaged to the screw shank.A surgical procedure was performed to remove and replace the affected part.
Additional Manufacturer Narrative
The affected yoke and mating lock screw that were removed and replaced were returned for evaluation.Evaluation is in process.
Additional Manufacturer Narrative
Fields updated: h6 updated to add codes for investigation findings and investigation conclusion.A review of production records did not identify any production or inspection issues related to the 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: 18539568
• Report Number: 3004638600-2024-00002
• Device Sequence Number: 18074339
• Product Code: NKB
• UDI-Device Identifier: 10840642163711
• UDI-Public: 10840642163711
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/19/2023

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: 664Y034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023; Not provided
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/22/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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