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

Model Number 11-4090

Device Problem Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

The removed rod and locking screws were returned for evaluation.Evaluation is in progress.Review of production records identified no issues related to production or inspection that may be associated to the reported event.

Event Description

At an unspecified time post-operatively, a surgical procedure was performed to address a loose rod in a pedicle screw construct.One rod and four locking screws were removed and replaced at that time.

Event Description

Four days post-operatively prior to patient discharge, one loose locking screw was identified radiographically.

Manufacturer Narrative

H10: mfg narrative update: the removed rod and locking screws were returned and evaluated.Visual inspection identified marking and deformation consistent with the reported event.Based on evaluation findings and the information reported, the exact root cause could not be determined.

• Brand Name: SNIPER SPINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL 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 dr.; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 17139879
• MDR Text Key: 317275005
• Report Number: 3004638600-2023-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10840642105759
• UDI-Public: 10840642105759
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11-4090
• Device Catalogue Number: 11-4090
• Device Lot Number: 542L27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• 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