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

Model Number 11-6401

Device Problem Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

The removed locking screw and concomitant offset connector were returned and evaluated.Visual inspection noted deformation consistent with the reported use and the removal technique.Functional evaluation found no functional issues with either returned unit.Review of production records identified no issues related to production or inspection that may be associated to the reported event.Based on the evaluation findings and the information available, the exact root cause of this event could not be established.

Event Description

At approximately two months post-operatively, a surgical procedure was performed to replace a loose locking screw that had disassociated from an offset connector in a pedicle screw construct.One locking screw and one connector were removed and replaced.

• 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 dr.; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 15597953
• MDR Text Key: 301678107
• Report Number: 3004638600-2022-00005
• 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
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11-6401
• Device Catalogue Number: 11-6401
• Device Lot Number: 662X061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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