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

Catalog Number	11-4002
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A single loose locking screw was identified approximately 17 months post-operatively following the extension of a pedicle screw construct.A reoperation was performed to remove and replace the affected hardware.

• Brand Name: SNIPER SPINE SYSTEM LOCKING SCREW
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 8580004
• Report Number: 3004638600-2019-00007
• Device Sequence Number: 3236756
• Product Code: MNH
• UDI-Device Identifier: 10840642105605
• UDI-Public: 10840642105605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 11-4002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention