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

Catalog Number	330-2505
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent a posterior lumbar interbody fusion surgical procedure on (b)(6) 2017 with placement of optimesh devices at the l4-l5 and l5-s1 levels and placement of a pedicle screw spinal construct.Following the surgical procedure, post-operative o-arm imaging revealed that the positioning and filling of both optimesh devices was adequate.The patient was reported to be "doing very well" upon discharge from the hospital.Approximately two months following the surgical procedure, the patient presented with new radicular leg pain.A ct scan was performed which revealed that bone was present in the central canal, there were fractures of transverse processes and spinous processes, and a possible s1 pedicle fracture.These findings appeared to be consistent with significant trauma.When questioned, the patient denied any trauma or deviation from the physician-prescribed post-operative care plan.The clinician did not consider this patient to be a reliable historian.The patient was returned to surgery on (b)(6) 2017 at which time a rupture of the optimesh device was observed.The optimesh device was removed and replaced with another optimesh device; however, there was no revision to the pedicle screw spinal construct.Upon discharge from the hospital, the patient was reported to have been "doing well clinically" with relief of his radicular pain.Approximately 1 month later, the patient returned with radicular lower extremity pain and reported that he had fallen in a hot tub.A ct scan was performed which revealed posterior migration of the optimesh device placed at the l5-s1 level into the spinal canal.There was no evidence of the optimesh device being damaged.The patient was returned to surgery and access to the lumbar spine was obtained through an anterior surgical approach.The optimesh device at the l5-s1 level was removed and replaced with an unspecified anterior interbody fusion device.Upon discharge from the hospital, the patient was reported to have been "doing well clinically" with relief of his radicular pain.

• 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: 6818577
• Report Number: 2135156-2017-00009
• Device Sequence Number: 101437
• Product Code: EZX
• UDI-Device Identifier: M7403302505
• UDI-Public: M7403302505
• 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): 08/24/2017

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: 04/01/2020
• Device Catalogue Number: 330-2505
• Device Lot Number: S15053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR