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	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On 9/18/2023 vertos was made aware, via an online article, of a lawsuit pertaining to a mild procedure.The lawsuit alleges that a mild procedure performed on (b)(6) 2022 resulted in injury to the dura and/or the spinal nerves due to a misidentification by the physician of scar tissue as ligamentum flavum.

• 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: 17953540
• Report Number: 3006450448-2023-00006
• Device Sequence Number: 6715637
• 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: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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: 09/18/2023
• Initial Report FDA Received Date: 10/17/2023
• 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: Disability
• Patient Age: 79 YR
• Patient Sex: Female