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

Catalog Number	300-3440
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient underwent an interbody fusion procedure with placement of an optimesh device on (b)(6) 2023 without incident.During a post-operative appointment, imaging showed the implant partially outside of the disc space with loss of graft containment.A revision surgery was conducted approximately 10 months post-operative to place an additional smaller optimesh device.

• 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 ; 6512568500
• MDR Report Key: 19346103
• Report Number: 2135156-2024-00005
• Device Sequence Number: 15082926
• Product Code: OQB
• UDI-Device Identifier: M7403003440
• UDI-Public: +M7403003440/$$3280301S24943F
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K230927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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 Catalogue Number: 300-3440
• Device Lot Number: S24943
• 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: 04/18/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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: 59 YR
• Patient Sex: Female