MAUDE Adverse Event Report: SPINEOLOGY INC. OPTIMESH; OPTIMESH SYSTEM

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Date 11/06/2023

Event Type  Injury  

Event Description

The patient underwent an optilif endo interbody fusion procedure via a tlif approach on (b)(6) 2023 at the l5/s1 level.Following the discectomy, a defect in the annulus was identified.The procedure continued with placement of an optimesh device.The surgeon opted to inspect the construct via anterior access due to concern of the annular defect.During this inspection, a laceration to the iliac vein was observed and successfully repaired.The patient currently has no clinical issues or complications.

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.Section d4: it is unknown which optimesh system device, if any, caused or contributed to the adverse event.

• Brand Name: OPTIMESH
• Type of Device: OPTIMESH SYSTEM
• 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: 18260620
• MDR Text Key: 329639186
• Report Number: 2135156-2023-00007
• Device Sequence Number: 1
• Product Code: OQB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230927
• 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: 12/04/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 77 YR
• Patient Sex: Female