MAUDE Adverse Event Report: SPINE WAVE, INC. LEVA TI PX DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT

Catalog Number 11-7012

Device Problem Collapse (1099)

Patient Problem No Code Available (3191)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Event report #mw5070292 received from fda through sus voluntary event reporting.The device was not available for evaluation.Review of dhr found no device issues for the indentified production lot.

Event Description

This event was reported on sus voluntary report mw5070292.

• Brand Name: LEVA TI PX DEVICE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton 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: 6728173
• MDR Text Key: 80546537
• Report Number: 3004638600-2017-00005
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10840642100037
• UDI-Public: 10840642100037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/09/2019
• Device Catalogue Number: 11-7012
• Device Lot Number: 661P257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention