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

Catalog Number 11-6400

Device Problem Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The pedicle screw construct removed was returned for evaluation.Evaluation is in process.

Event 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.

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 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.

• 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: 17958568
• MDR Text Key: 325963016
• Report Number: 3004638600-2023-00011
• 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: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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