MAUDE Adverse Event Report: SPINEOLOGY, INC. OPTIMESH; MESH, GRAFT CONTAINMENT

Catalog Number 330-2505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

The cause of the adverse event could not be determined with the available information.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 or admission that a device has malfunctioned or that a device is related to an injury or death.

Event Description

As reported by the surgeon: the patient underwent an l5-s1 interbody fusion with placement of an optimesh device with bone graft in a very collapsed disc space without incident on (b)(6) 2019.The patient awoke with prior symptoms resolved but complained of new stiffness in right leg with pain and numbness in right foot.These symptoms persisted and a ct scan on (b)(6) 2019 showed good restoration of disc height and filling of the optimesh device but also allograft bone in the central canal and right neuro-foramen.A revision surgery was performed on (b)(6) 2019 and the bone in the canal was removed.Symptoms remained persistent and a new ct scan during the week of (b)(6) 2019 still showed bone in the right neuro-foramen.The surgeon recommended a nerve root injection and, if symptoms persist, a second revision surgery to remove the remaining bone.The last available patient status update indicates that a second opinion was sought.

• Brand Name: OPTIMESH
• Type of Device: MESH, GRAFT CONTAINMENT
• Manufacturer (Section D): SPINEOLOGY, INC.; 7800 3rd street n.; suite 600; saint paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY, INC.; 7800 3rd street n.; suite 600; saint paul MN 55128 5455
• Manufacturer Contact: andrew adams ; 7800 3rd street n.; suite 600; saint paul, MN 55128-5455 ; 6512568500
• MDR Report Key: 9292875
• MDR Text Key: 166944945
• Report Number: 2135156-2019-00008
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 330-2505
• Device Lot Number: S81053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• 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): Other
• Patient Age: 66 YR