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	Hematoma (1884)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a vertos representative was informed by a physician that a female patient he had performed a mild procedure on was diagnosed with a hematoma.The mild procedure was under iv mac sedation and no epidurogram was used.The vertos representative was not present during this procedure and details of the events as well as the date of the mild procedure are currently unknown due to the physician being on a three-week vacation after initialing reporting this event to the vertos representative.
Event or Problem Description
On 2/22/2023, a vertos representative was informed by a physician that a female patient, who had the mild procedure on (b)(6) 2023, was diagnosed with a hematoma.The mild procedure was under iv mac sedation and no epidurogram was used.The procedure was performed in accordance with the ifu and physician training.The vertos representative was not present during this procedure.It was reported the patient was diagnosed with a hematoma the following day.The hematoma was at the same level as the mild procedure.The patient was admitted to the hospital and decompression (laminectomy) was performed on (b)(6) 2023.The patient was discharged following the laminectomy and is reportedly doing well.

• 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: 16599734
• Report Number: 3006450448-2023-00002
• Device Sequence Number: 17973047
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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