OPTIMESH 330-2505

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-24 for OPTIMESH 330-2505 manufactured by Spineology Inc..

Event Text Entries

[83610215] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2135156-2017-00009
• MDR Report Key: 6818577
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2017-08-24
• Date of Report: 2017-08-24
• Date of Event: 2017-07-12
• Date Mfgr Received: 2017-07-12
• Device Manufacturer Date: 2015-03-05
• Date Added to Maude: 2017-08-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JACQUELINE HAUGE
• Manufacturer Street: 7800 3RD STREET N. SUITE 600
• Manufacturer City: ST. PAUL MN 551285455
• Manufacturer Country: US
• Manufacturer Postal: 551285455
• Manufacturer G1: SPINEOLOGY INC.
• Manufacturer Street: 7800 3RD STREET N. SUITE 600
• Manufacturer City: ST. PAUL MN 551285455
• Manufacturer Country: US
• Manufacturer Postal Code: 551285455
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPTIMESH
• Generic Name: SURGICAL MESH
• Product Code: EZX
• Date Received: 2017-08-24
• Catalog Number: 330-2505
• Lot Number: S15053
• Operator: PHYSICIAN
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SPINEOLOGY INC.
• Manufacturer Address: 7800 3RD STREET N. SUITE 600 ST. PAUL MN 551285455 US 551285455

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-08-24