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

Catalog Number	11-6400
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pedicle screw construct removed was returned for evaluation.Evaluation is in process.
Event or Problem Description
During a revision surgery of an existing long construct unrelated to the manufacturer's device, two screw yokes were found un-engaged to the screw heads.
Additional Manufacturer Narrative
Fields updated: b5: additional description of the event, d4: lot number, h2: type of follow-up = device evaluation, h3: device evaluated: yes, h4: manufacture date and h6: type of investigation, investigation findings and investigation conclusion codes.A review of production records did not identify any production or inspection issues related to the event.
Event or Problem Description
Pedicle screw fixation construct was being revised due to a patient with what was described as poor bone quality requiring an alternate type of fixation.
Additional Manufacturer Narrative
Fields updated: d1: add trademark symbol to brand name to be consistent with gudid.D4: correct error in udi #.

• Brand Name: SALVO® SPINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL 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: 17958568
• Report Number: 3004638600-2023-00011
• Device Sequence Number: 7120367
• 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,Followup
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11-6400
• Device Lot Number: 664X005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023; Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/03/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Sex: Unknown