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	Pneumocephalus (4587)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 a 220 pound, 68 year old female patient underwent a bilateral l4-l5 mild procedure.The procedure was reportedly performed without issue, and an epidural was performed as well using loss of resistance.On (b)(6) 2023, the physician reported the patient went to the emergency room in the early hours of 5/4 with a headache.After some imaging, the patient was diagnosed with pneumocephalus.Patient was discharged within 24 hours and is doing fine.

• 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: 16994543
• Report Number: 3006450448-2023-00003
• Device Sequence Number: 17895673
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 100 KG