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

Catalog Number 300-3440

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

The patient underwent an interbody fusion procedure with placement of an optimesh device on (b)(6) 2022 through a transiliac approach.The implantation of the device was completed as intended and without patient consequence, however, when releasing the mesh implant, a disposable portion of the insertion instrumentation remained in the patient.A separate incision was made for attempted removal of the component, but it was found firmly embedded between the disc space and in the ilium.The surgeon opted to leave the component implanted.The patient currently has no clinical issues or complications.

• 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: 13776863
• MDR Text Key: 289725465
• Report Number: 2135156-2022-00002
• Device Sequence Number: 1
• Product Code: OQB
• UDI-Device Identifier: M74030034400
• UDI-Public: +M74030034400/$$3260701S21932C
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300-3440
• Device Lot Number: S21932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: 36 YR