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

Catalog Number	300-3032
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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.
Event or Problem Description
The patient underwent an interbody fusion procedure with placement of an interbody fusion device on (b)(6) 2024.During the surgical procedure, the distal tip of a bone fill tube bent when filling the implant and could not be easily removed from the inserter.Upon forceful removal, the inserter assembly withdrew from the access tube shearing off the bent distal tip of the bone fill tube and unintentionally releasing the mesh implant.A separate incision and surgical approach were necessary to remove the sheared tip and replace the partially filled implant.

• 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: 19839210
• Report Number: 2135156-2024-00014
• Device Sequence Number: 17791635
• Product Code: OQB
• UDI-Device Identifier: M7403003032
• UDI-Public: M7403003032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 300-3032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Male