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 03/08/2023

Event Type  Injury  

Manufacturer Narrative

The removed locking screws and concomitant offset connectors were returned for evaluation.Review of production records identified no issues related to production or inspection that may be associated to the reported event.Evaluation is in progress.

Event Description

At approximately nine months post-operatively, a surgical procedure was performed to replace loose locking screws that had disassociated from a multi-level pedicle screw revision construct extension.Four locking screws and two connectors were removed and replaced.

Manufacturer Narrative

Fields updated: h2: type of follow-up =-device evaluation, h3: device evaluated = yes and h6: investigation findings and investigation conclusion codes.

• 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: 17274018
• MDR Text Key: 318547979
• Report Number: 3004638600-2023-00006
• 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,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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: 663W077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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