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

Catalog Number	CAL-VLY2643
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned for evaluation.The complaint details provided do not indicate whether the event is related to the device, the surgical technique, surgeon experience and/or patient anatomy.No further information was obtained from the user.
Event or Problem Description
Dr.(b)(6) corrected a failed sacrocolpopexy originally done by a different surgeon with vertessa lite.He stated that in his conversation with the patient, that the failure occured about one week post-op.Per dr.(b)(6), product was tensioned too tight.

• Brand Name: VERTESSA LITE Y-MESH
• 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; suite 140; westlake village CA 91361
• Manufacturer Contact: alia hafez ; 4360 park terrace dr; westlake village, CA 91361 ; 8188796556
• MDR Report Key: 21450378
• Report Number: 3003990090-2024-01587
• Device Sequence Number: 17971980
• Product Code: OTO
• UDI-Device Identifier: 00890594000469
• UDI-Public: 00890594000469
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2025
• 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: Required Intervention
• Patient Sex: Female