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 12/06/2023

Event Type  Injury  

Event 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.

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.

• 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; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 18449964
• MDR Text Key: 332169093
• Report Number: 3004638600-2024-00001
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 663Y081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2023
• 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