MAUDE Adverse Event Report: VERTOS MEDICAL INC. VERTOS MILD DEVICE KIT

Model Number	MDK-0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, a female patient underwent a bilateral, 2 level mild procedure.An epidurogram was performed at the level above using a 20 gauge touhy needle.The patient was reported to be of average size and weight and stopped all medications including anticoagulants 7-10 day before the procedure.The patient had issues of hypotension during the procedure and was treated with 20mg ephedrine and a 500ml bolus of fluid.The physician had some imaging issues due to the anatomy and seeing markers that resulted in using more that 15 minutes of fluoroscopy time.The patient complained of neurogenic claudication and back pain the next day ( on (b)(6)2022).An mri was performed and showed "heterogeneous bilobed fluid collection in the dorsal epidural space along the dorsal thecal sac.Fluid collection represented post op hematoma given characteristics".The patients pain continued for 1 week when a surgical intervention for the subdural hematoma was performed on (b)(6) 2022.The surgeon did not find a dorsal epidural tear.There was an osteophyte noted on the facet going medially with a "small vessel above it that may have been injured during the procedure" - this was their best guess.The patient is reportedly doing well after the subdural hematoma was addressed.Off all pain medication and much better functionally.There is nothing in the information that was obtained that suggests any device malfunction contributed to this event.Patient selection (difficult anatomy) may have contributed to this event.

• Brand Name: VERTOS MILD DEVICE KIT
• Common Device Name: MILD DEVICE KIT
• Manufacturer (Section D): VERTOS MEDICAL INC.; 95 enterprise ste. 325; aliso viejo CA 92656
• Manufacturer (Section G): VERTOS MEDICAL INC.; 95 enterprise ste. 325; aliso viejo CA 92656
• Manufacturer Contact: lisa maloney ; 95 enterprise ste. 325; aliso viejo, CA 92656 ; 9495385252
• MDR Report Key: 19715571
• Report Number: 3006450448-2024-00009
• Device Sequence Number: 8920478
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2024

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: Health Professional
• Device Model Number: MDK-0001
• Device Catalogue Number: MDK-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female