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 Codes	Dural Tear (1417); Cerebrospinal Fluid Leakage (1772)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10/31/2024, a vertos representative reported that a female patient, who was under treatment for a multi-level l3/l4 and l4/l5 mild procedure on the same day, exhibited evidence of a csf leak during the procedure.The operating physician confirmed that the dura was punctured during treatment while using the mild device kit, resulting in the csf leak.The patient did not show any symptoms beyond the csf leak while she remained laying down on the operating table, but did experience headaches sitting up soon after the procedure.A blood patch was performed to remedy the dura puncture following the mild procedure, and the patient was discharged about an hour after the procedure was completed.The patient was reported to have a post lumbar spinal fusion at the l4/l5 level prior to the mild procedure, but otherwise observed with no other unusual anatomy.There have been no further post-operative symptoms from the patient reported following her discharge from the hospital.

• 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: 20748208
• Report Number: 3006450448-2024-00016
• Device Sequence Number: 20904766
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/21/2024

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: 10/31/2024
• Initial Report FDA Received Date: 11/21/2024
• 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