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	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), a patient had the mild procedure at the bilateral l1-l2 and l2-l3 with no epidurogram.It was reported that two days following the procedure on (b)(6) the patient had increased pain going down to the knees after resuming their blood thinner medication.The patient was admitted to the hospital on (b)(6) with leg weakness and trouble walking and was diagnosed with an epidural hematoma.He was admitted to the hospital, and a surgical hematoma evacuation was performed at t12-l1.The patient was discharged on (b)(6) and did not go to the mild follow up appointment and has not spoken to the mild physician or his team.The current status of the patient is unknown.

• 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: 17337389
• Report Number: 3006450448-2023-00005
• Device Sequence Number: 15107525
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2023

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
• 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: 06/20/2023
• Initial Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 136 KG