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	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a physician reported a patient developing a hematoma post-operatively after a mild procedure was completed on (b)(6) 2023.The patient initially complained of hip pain and weakness following the mild procedure, but the physician had diagnosed the concerns within normal post-operative range; however, the following day after the mild procedure on (b)(6) 2023, the patient exhibited issues standing and walking, after which the patient was admitted to the er.The last status reported was that the patient is under care and was assessed for potential decompression; no additional information of the patient's current condition has been made available at this time.The patient was reported to have prior hip replacement surgeries; however, there were no reported concerns with the patient's anatomy or eligibility for the mild procedure prior to operation.

• 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: 18504344
• Report Number: 3006450448-2023-00011
• Device Sequence Number: 8087357
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/12/2024

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: 12/18/2024
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown