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); Muscle Weakness/Atrophy (1967); Paralysis (1997)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12/9/21, a company representative was contacted by two professional acquaintances, one of whom told of a rumor that a mild patient was in the emergency room at (b)(6) from apparent complications.After further investigation, the company rep spoke to some (b)(6) physicians who mentioned that one of their neurosurgeons had treated a patient post mild procedure.The rep reported this back to a physician customer, who does mild procedures at a facility in the (b)(6).The dr's office investigated and found that one of his patients had a mild procedure on (b)(6) 2021 and had called about post-op pain.The dr.Instructed the patient to go to the emergency room if the pain got worse but did not hear further about what happened.In (b)(6) of 2022, a professor in pain management at (b)(6) who was not involved with the patient's case followed up on the rumors and spoke to the dr.And the neurosurgeon.According to the professor: the patient had been admitted to the emergency room at (b)(6) on (b)(6) 2021 with motor/sensory loss, decreased motor strength, and dorsal flexion of the left leg; the neurosurgeon offered surgery but the patient initially refused; on (b)(6) 2021, neurosurgeon performed decompressive laminotomy surgery (not a mild procedure) on the patient and cited a dural tear at l-4; the neurosurgeon believed that the post-op symptoms were due to the dural tear and that the dural tear was due to the original mild procedure based on the fact that the patient was admitted to the hospital the next day.There was a prior closed complaint involving the same mild procedure of (b)(6) 2021 performed by the mild dr.In that complaint, two of the devices in the mild kit were damaged during use resulting in the procedure being completed with a second mild kit, with no reported harm to the patient.Investigation found no device malfunction, and vertos was not made aware of the patient's post-op symptoms.There has been no additional information about the patient's condition or the details of the (b)(6) 2021 post mild procedure surgery.After review of the available information and the medical judgement report, there is insufficient information to confirm that the dural tear occurred during the original mild procedure of (b)(6) 2021.All the information was provided by the (b)(6) professor and not directly from the facility or neurosurgeon.The only details considered confirmed are that the patient experienced post-op symptoms after the mild procedure, was admitted to the emergency room, and underwent a decompressive surgery on (b)(6) 2021.There is no evidence to suggest device malfunction was involved with the post-op symptoms or dural tear.

• 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: 19715644
• Report Number: 3006450448-2024-00007
• Device Sequence Number: 8778382
• 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): 07/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2025
• Device Model Number: MDK-0001
• Device Catalogue Number: MDK-0001
• Device Lot Number: 062821-00560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2021
• 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