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	Hematoma (1884); Pain (1994)
Date of Event	01/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a male patient with some scoliosis and a small spondylolisthesis had a bilateral l1-l2 mild procedure performed.An epidural was performed with the mild procedure.Nothing abnormal was reported regarding the procedure.The patient had also reportedly stopped their anticoagulants in an appropriate timeline prior to surgery.The patient woke from the procedure with excruciating groin pain.The physician stated that the patient had no motor deficits and was able to walk out of the surgery center.The physician recommended that the patient should be seen in the er after discharge.An mri was performed and showed blood around the treatment area of the mild procedure and an emergency laminectomy was performed.The patient was hospitalized because of this event.The patients' pain has improved post laminectomy according to the physician.

• 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: 18899489
• Report Number: 3006450448-2024-00002
• Device Sequence Number: 18114500
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/13/2024

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: Not provided
• Initial Report FDA Received Date: 03/13/2024
• 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: Male