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

Catalog Number	11-4640
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
At approximately 17 months post-operatively, two broken pedicle screws were identified at the s1 vertebral level of a two-level pedicle screw construct.A surgical procedure was performed to remove the affected hardware.

• Brand Name: SNIPER 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: 9292527
• Report Number: 3004638600-2019-00012
• Device Sequence Number: 2448777
• Product Code: MNH
• UDI-Device Identifier: 10840642106411
• UDI-Public: 10840642106411
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K100605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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: 11-4640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 11/07/2019
• 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