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

Catalog Number 300-3440

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/25/2023

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.Pursuant to manufacturer policy, events resulting in a revision surgery are deemed a serious injury as defined in 21 cfr 803.3 and are determined to be mdr reportable events.

Event Description

The patient underwent an interbody fusion procedure with placement of an optimesh device without incident.Approximately one (1) month later, the patient experienced recurring back pain, prompting medical attention.Imaging showed presence of bone graft in the foraminal space per surgeon interpretation.A revision surgery was conducted on (b)(6) 2023 to remove and replace the implant.

• Brand Name: OPTIMESH
• Type of Device: INTERVERTEBRAL BODY 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: megan polos ; 7800 3rd street n.; suite 600; saint paul, MN 55128-5455
• MDR Report Key: 16418765
• MDR Text Key: 309986952
• Report Number: 2135156-2023-00001
• Device Sequence Number: 1
• Product Code: OQB
• UDI-Device Identifier: M74030034400
• UDI-Public: +M74030034400/$$3270801S24136D
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-3440
• Device Lot Number: S24136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: 64 YR
• Patient Sex: Male