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

Catalog Number	11-4002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgeon removed the entire construct consisting of screws, rods and locking screws.Returned for evaluation were four (4) locking screws - two (2) units of production lot 662p040, one (1) unit of production lot 661p024 and one (1) unit of production lot 663n047.The returned devices were evaluated.Visual inspection of each locking screw found visual indicators consistent with use in a pedicle screw construct.Minor deformation and wear were observed.The remaining parts of the construct removed were also returned - two (2) pedicle screws and two (2) spinal rods these units were inspected and were found to exhibit similar signs of use.Further evaluation found no functional defects.A review of the device history production records for all returned product production lots found these products all met specifications for release.No definitive conclusion can be drawn.
Event or Problem Description
During a surgical procedure to extend an existing construct, it was reported that the surgeon noted two separated locking screws.The fixation construct was replaced during this procedure.The surgeon reported that the original surgery had been performed approximately two years earlier and the patient was fused at the original operative level.

• 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: 8311302
• Report Number: 3004638600-2019-00003
• Device Sequence Number: 1650251
• Product Code: NKB
• UDI-Device Identifier: 10840642105605
• UDI-Public: 10840642105605
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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 Catalogue Number: 11-4002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1