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

Model Number	11-6530
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During routine post-operative follow up, four weeks post-operatively, the surgeon identified a separated screw in the pedicle screw construct via radiograph.The pedicle screw and construct were left in place as the surgeon reported the patient is asymptomatic.

• Brand Name: SALVO SPINE SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 10906766
• Report Number: 3004638600-2020-00005
• Device Sequence Number: 16676085
• Product Code: NKB
• UDI-Device Identifier: 10840642132984
• UDI-Public: 10840642132984
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11-6530
• Device Catalogue Number: 11-6530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1