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

Catalog Number	10-4100.2
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A broken fragment of the device was identified during routine radiographic patient follow up.Although the patient was asymptomatic, the surgeon elected to perform a surgical procedure to retrieve the fragment.No complications from either surgical procedure have been reported.

• Brand Name: SNIPER SPINE SYSTEM
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 7149430
• Report Number: 3004638600-2017-00010
• Device Sequence Number: 16401949
• Product Code: MNH
• UDI-Device Identifier: 10840642108118
• UDI-Public: 10840642108118
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: Physician
• Device Catalogue Number: 10-4100.2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/27/2017
• 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