MAUDE Adverse Event Report: SPINEOLOGY, INC OPTIMESH; INTERVERTEBRAL BODY GRAFT CONTAINMENT

Catalog Number 300-3032

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Vascular Problem (4441); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The information contained in this report is being provided to fda to comply with medical device reporting regulations and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination of admission that a device has malfunctioned or that a device is related to an injury or death.

Event Description

The patient underwent an interbody fusion procedure with placement of an optimesh device with bone graft on (b)(6) 2021.Following placement of the device, images showed the mesh implant partially through the ventral annulus.A cta diagnostic raised concern the mesh may be restricting flow to an artery.One day later, a revision surgical procedure was conducted via anterior approach to remove the mesh implant and replaced with an alternate interbody fusion device.The reoperation was completed as intended and without patient consequence.The patient has no clinical issues or complications and is doing well per the surgeon.

• Brand Name: OPTIMESH
• Type of Device: INTERVERTEBRAL BODY GRAFT CONTAINMENT
• Manufacturer (Section D): SPINEOLOGY, INC; 7800 3rd street north; suite 600; saint paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY, INC; 7800 3rd street north; suite 600; saint paul MN 55128 5455
• Manufacturer Contact: andrew adams ; 7800 3rd street north; suite 600; saint paul, MN 55128-5455 ; 6512568500
• MDR Report Key: 12304790
• MDR Text Key: 265978836
• Report Number: 2135156-2021-00005
• Device Sequence Number: 1
• Product Code: OQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN200010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-3032
• Device Lot Number: S21620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Patient Age: 75 YR