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

Model Number	10-10-100-4
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a two-level interbody fusion procedure with placement of two optimesh devices without incident.Approximately one (1) month later, the patient experienced recurring leg pain, prompting medical attention.Imaging showed obstruction in the canal.A revision surgery was conducted to remove and replace both implants with a static cage.This report applies to optimesh device two of two.
Additional Manufacturer Narrative
The information contained in this report is being provided to the 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.

• Brand Name: OPTIMESH
• Common Device Name: 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 ; 6512568505
• MDR Report Key: 17171206
• Report Number: 2135156-2023-00005
• Device Sequence Number: 6649443
• Product Code: OQB
• UDI-Device Identifier: M7403002628
• UDI-Public: +M7403002628/$$3271001S24404B
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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 Model Number: 10-10-100-4
• Device Catalogue Number: 300-2628
• Device Lot Number: S24404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male