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

Catalog Number	11-7012
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This event was reported on sus voluntary report mw5070292.

• Brand Name: LEVA TI PX DEVICE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton 06484
• MDR Report Key: 6728173
• Report Number: 3004638600-2017-00005
• Device Sequence Number: 16376786
• Product Code: MAX
• UDI-Device Identifier: 10840642100037
• UDI-Public: 10840642100037
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 09/09/2019
• Device Catalogue Number: 11-7012
• Device Lot Number: 661P257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention