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	Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 a physician performed a bilateral l3-l4, l4-l5 mild procedure on a 75y/o female patient with a history of urinary incontinence (2008) and osteoarthritis.From imaging, the patient was noted to have severe stenosis, grade 1 spondylolisthesis, and facet cyst.The case reportedly went well.On (b)(6) 2022 the patient went to the emergency room due to urinary incontinence and numbness in the genital area.The patient was placed in the care of a neurosurgeon.An mri was performed and there was no evidence of an epidural hematoma, however the stenosis was worse than prior to the procedure.The patient was diagnosed with cauda equina syndrome, a buckled ligament at l4-l5, and underwent emergent surgery.The patient is currently stable, full strength in legs, worsened urinary retention and has improvement in numbness.Updated report from treating physician dated (b)(6) 2022 stated that patient remained in the hospital and remain flat for 7 days before discharge following the emergent surgery because of a csf leak.At the time of the complaint investigation, the patient was in rehab due to ongoing urinary incontinence.The physicians' patient selection and pre-procedure evaluation (grade 1 spondylolisthesis, facet cyst, severe stenosis - with no documented flexion/extension images to check for stability) may have contributed to the occurrence of this incident.

• 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: 19715435
• Report Number: 3006450448-2024-00008
• Device Sequence Number: 15582011
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 03/17/2022
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 74 KG