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

Model Number 11-4002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Visual inspection of the returned product found deformation consistent with the reported event.Review of production records identified no issues related to production or inspection.Based on the evaluation findings and the information available, the exact root cause of this event could not be established.

Event Description

Approximately 5 months post-operatively during routine follow-up, it was noted on radiograph that locking screws appeared to be separated from the construct.A surgical procedure was performed at which time the surgeon replaced the locking screws and a single pedicle screw.

• Brand Name: SNIPER SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 11127762
• MDR Text Key: 225499856
• Report Number: 3004638600-2021-00001
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10840642105605
• UDI-Public: 10840642105605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11-4002
• Device Catalogue Number: 11-4002
• Device Lot Number: 663U103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention