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	12/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, a 74 y/o female patient had a bilateral l4-l5 mild procedure.The patient had been on anticoagulants that were reportedly stopped in an appropriate timeine before the procedure.An epidurogram was reported as performed at l3-l4 due to difficulty accessing the l4-l5 for the epidurogram.There was no reported device malfunction and the device performed as intended.Approximately 2 hours following the procedure, the patient complained of severe back pain and leg weakness and went from home to the er.An mri was performed, and an epidural hematoma was identified.The patent underwent spine surgery and had the hematoma evacuated one day after the mild procedure.It was reported that the hematoma was at t-11 and the mild procedure was performed much lower at l4-l5 with epidurogram at l3-l4 in the lumbar spine therefore it cannot be determined what caused the hematoma.The patient recovered after the uneventful surgery.

• 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: 19715635
• Report Number: 3006450448-2024-00006
• Device Sequence Number: 12956246
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/10/2024

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: 12/10/2020
• Initial Report FDA Received Date: 07/10/2024
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 72 KG