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

Model Number 11-4741

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2019

Event Type  malfunction  

Event Description

During a procedure to install a 10-level pedicle screw construct, the surgeon reported a single screw separated during attempted placement into the ilium.The screw was partially removed and the construct completed.

Manufacturer Narrative

The removed portion of the device was returned and the reported event was confirmed.The returned device displayed visual indications of use in a manner that exceeded the strength of the assembly.A review of the dhr found no nonconformances.Based on the results of the evaluation a definitive conclusion cannot be made.

• Brand Name: SNIPER SPINE SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 10490666
• MDR Text Key: 206778520
• Report Number: 3004638600-2019-00013
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10840642106541
• UDI-Public: 10840642106541
• Combination Product (y/n): N
• PMA/PMN Number: K152174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11-4741
• Device Catalogue Number: 11-4741
• Device Lot Number: 942R22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1