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

Catalog Number 11-6400

Device Problem Premature Separation (4045)

Patient Problem Failure of Implant (1924)

Event Date 12/18/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

The affected yoke and mating lock screw that were removed and replaced were returned for evaluation.Evaluation is in process.

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.

• Brand Name: SALVO SPINE SYSTEM
• Type of Device: 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: 18539568
• MDR Text Key: 333179104
• Report Number: 3004638600-2024-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10840642163704
• UDI-Public: 10840642163704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention