MAUDE Adverse Event Report: VERTOS MEDICAL INC. VERTOS MILD DEVICE KIT

Model Number MDK-0001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

On (b)(6) 2023 a patient with severe spinal stenosis underwent a multi-level mild procedure.A company representative, who was present during the procedure, reported that it was uneventful and completed without any issues.On (b)(6) 2023, the treating physician reported to the company representative that approximately one to two days post op, the patient was admitted to the hospital with cauda equina syndrome.The patient underwent an emergency procedure (either a laminectomy or a fusion).The exact date of the emergency procedure and status of the patient is unknown at the time of this report.

• Brand Name: VERTOS MILD DEVICE KIT
• Type of Device: 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: 18156375
• MDR Text Key: 328352200
• Report Number: 3006450448-2023-00007
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female