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

Model Number 11-6530

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Visual inspection of the returned device found deformation consistent with the reported event.Review of production records found no issues related to production or inspection.Based on the evaluation and information available, the exact root cause of this event could not be established.

Event Description

Post-operatively, the surgeon identified a separated screw in the pedicle screw construct via radiograph.A surgical procedure was performed to replace the yoke while leaving the screw and remaining construct in place.

• Brand Name: SALVO SPINE SYSTEM
• Type of Device: 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 drive; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 10931926
• MDR Text Key: 219129445
• Report Number: 3004638600-2020-00006
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10840642132984
• UDI-Public: 10840642132984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11-6530
• Device Catalogue Number: 11-6530
• Device Lot Number: 661V072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2020
• 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