MAUDE Adverse Event Report: SPINEOLOGY INC. OPTIMESH; SURGICAL MESH

Catalog Number	330-2005
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	02/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the patient underwent a posterior lumbar spinal fusion with placement of a 1500e optimesh implant.Approximately 4 weeks following the surgical procedure, the patient experienced back pain and a fever.On (b)(6) 2017, the patient was returned to the operating room for posterior lumbar exploratory surgery at which time the physician identified an infection localized to the intervertebral disc space.The optimesh devices was removed and cultures were taken.A new interbody fusion device was not placed.Microbiological results of the culture identified an anerobic infection consistent with anaerobes commonly found in mucosal membranes.At an unspecified time following the re-operation procedure, the patient was again returned to the operating room for anterior lumbar placement of another manufacturer's interbody fusion device.

• Brand Name: OPTIMESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; st. paul MN 55128 5455
• MDR Report Key: 6377254
• Report Number: 2135156-2017-00003
• Device Sequence Number: 1002443
• Product Code: EZX
• UDI-Device Identifier: M7403302005
• UDI-Public: M7403302005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K014200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

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: Physician
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 330-2005
• Device Lot Number: S14273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/03/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: E SHAPER BLADE; EXCHANGE TUBE; GUIDE PIN; POWERED TISSUE EXTRACTOR BRUSH; SEQUENTIAL DILATOR SET; VERIFY DEVICE
• Outcome Attributed to Adverse Event: Other