MAUDE Adverse Event Report: SPINE WAVE, INC. VELOCITY L EXPANDABLE INTERBODY DEVICE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	11-2366
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 2 weeks post-operatively, it was noted on imaging that the implant had moved.A surgical procedure was performed at which time the implant was removed and replaced and supplemental fixation was added.

• Brand Name: VELOCITY L EXPANDABLE INTERBODY DEVICE
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 8446162
• Report Number: 3004638600-2019-00005
• Device Sequence Number: 3056691
• Product Code: MAX
• UDI-Device Identifier: 10840642106879
• UDI-Public: 10840642106879
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 11-2366
• Device Lot Number: 744T18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention