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	Skin Infection (4544)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient who was treated on 6/25 with a bilateral l3-l4 mild procedure, was seen in office by the treating physician as follow-up on 7/22 with site tenderness, fluctuant, and drainage was determined to have developed an infection.An mri with contrast showed 9mm subcutaneous enhancing collection concerning for access at the l4-5 level with extension of inflammation into the bilateral paraspinal muscles (r>l).There was no concern for extension into the spinal canal.The patient's post-procedural pain was manageable, and the patient denied experiencing any symptoms of fevers, chills, weakness, numbness, or incontinence after the mild procedure.Information such as the patient's adherence to any recovery regiment, including the patient's last steroid use during recovery, diabetic status, or any previous health issues with post-procedural healing or ongoing systemic infections could not be obtained.The patient was treated in the hospital with iv antibiotics for the infection and discharged on 7/25a patient who was treated on 6/25 with a bilateral l3-l4 mild procedure, was seen in office by the treating physician as follow-up on 7/22 with site tenderness, fluctuant, and drainage was determined to have developed an infection.An mri with contrast showed 9mm subcutaneous enhancing collection concerning for access at the l4-5 level with extension of inflammation into the bilateral paraspinal muscles (r>l).There was no concern for extension into the spinal canal.The patient's post-procedural pain was manageable, and the patient denied experiencing any symptoms of fevers, chills, weakness, numbness, or incontinence after the mild procedure.Information such as the patient's adherence to any recovery regiment, including the patient's last steroid use during recovery, diabetic status, or any previous health issues with post-procedural healing or ongoing systemic infections could not be obtained.The patient was treated in the hospital with iv antibiotics for the infection and discharged on 7/25.

• 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: 20072506
• Report Number: 3006450448-2024-00011
• Device Sequence Number: 3034888
• 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): 08/26/2024

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: 07/23/2024
• Initial Report FDA Received Date: 08/26/2024
• 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: Hospitalization
• Patient Sex: Female
• Patient Weight: 64 KG