MAUDE Adverse Event Report: CALDERA MEDICAL INC. VERTESSA LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC: OTO

Catalog Number	CAL-VLY2643
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no information provided from the physican about the patient or details of what happened during the surgery or if the patient was harm.A "complete pull through at the sacrum" with vertessa lite usually happens when the implant doesn't hold properly in the bone.This can be due to placement issues, a weak sacrum, or the implant not bonding well.It can also occur if an infection weakens the area.Without product lot numbers or product return, a further evaluation of the issue cannot be conducted.The complaint details provided do not indicate whether the event is related to the product, the surgical technique, surgeon experience and/or patient anatomy.
Event or Problem Description
Dr.(b)(6) mentioned that she "had a couple of failures of vertessa lite" which occurred by a "complete pull through at the sacrum." she mentioned that they happened "recently" however, did not clarify when they had occurred and when the patients had their first surgery.No product was returned and no additional information was communicated.

• Brand Name: VERTESSA LITE
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC: OTO
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL INC.; 4360 park terrace dr.; westlake village CA 91361
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr.., suite 140; westlake village 91361 ; 8188796555
• MDR Report Key: 22560070
• Report Number: 3003990090-2025-01596
• Device Sequence Number: 13171089
• Product Code: OTO
• UDI-Device Identifier: 00890594000469
• UDI-Public: 00890594000469
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150023
• 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
• Report Date (Section B): 07/21/2025

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 Catalogue Number: CAL-VLY2643
• Device Lot Number: UNKNOWN
• 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: Not provided
• Initial Report FDA Received Date: 07/21/2025
• 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: Other
• Patient Sex: Female