MAUDE Adverse Event Report: SPINE WAVE, INC. LEVA ANTERIOR INTERBODY SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 11-0953

Device Problem Malposition of Device (2616)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

This event was confirmed by radiograph.Device was not returned therefore no evaluation could be performed.A review of the device history record found device met all specifications for release.

Event Description

The surgeon reported that one screw in an anterior cage construct was out of position as noted on radiograph approximately 6 weeks following an anterior lumbar interbody fusion procedure.A reoperation was performed to replace the construct.

• Brand Name: LEVA ANTERIOR INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 7790927
• MDR Text Key: 117419600
• Report Number: 3004638600-2018-00013
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 10840642108156
• UDI-Public: 10840642108156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2019
• Device Catalogue Number: 11-0953
• Device Lot Number: 664P007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2016
• 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