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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Vertos medical was made aware of a published medical journal article dated 12/25/2023, in which a 76 year old female patient was reported to have post-procedural complications immediately following a left l2/l3 mild procedure, inclusive of lower back/sacral pain and lower extremity weakness resulting from an acute epidural hematoma.The article states the patient was presented to the emergency room for surgical evacuation, which resulted in a good outcome without any further complications.There was no information in the article related to the mild procedure, inclusive of any device traceability, operating facility, operating physician, and the event date.Vertos medical attempted to obtain such information from the article authors; however, the authors could not provide any information in accordance with hipaa policy.Additionally, there was no device information documented in the article, inclusive of any devices involved with the related procedure or any allegations of any device malfunctions.

• 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: 18611085
• Report Number: 3006450448-2024-00001
• Device Sequence Number: 7416819
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• 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): 01/30/2024

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: 01/02/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 76 YR
• Patient Sex: Female