MAUDE Adverse Event Report: CALDERA MEDICAL INC. TVT EXACT RETROPUBIC SYSTEM; TVT-CAL-EXACT

Model Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Incontinence (4572)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was conducted on the received product and the batch record file.The product was decontaminated and properly packaged.The received device was manipulated and explanted, but the original packaging and all other components were missing.Only three parts of the mesh were visible, surrounded by a significant amount of organic matter.Based on this evaluation, the complaint is not associated with a manufacturing issue; the product conformed to specifications upon release.Events of this nature are regularly trended.Therefore, this complaint will be closed for trending purposes.The manufacturing number is (b)(4).
Event or Problem Description
Placement of an exact tvt-type retropubic strip was performed on (b)(6) 2024.Recently, there has been an unfavorable development in urinary status, with a progressive deterioration in continence.Currently, the patient requires a urinary protection device during the day, which is usually saturated by the end of the day, and there is no night protection in place.Significant leaks occur during physical exertion, especially during mobilization.The patient also experiences dysuria and requires abdominal pressure to initiate urination.Urgency is noted as marked (++).The strip was subsequently removed, and an ams 800 artificial urinary sphincter was inserted.On (b)(6) 2025, the artificial sphincter was implanted.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Common Device Name: TVT-CAL-EXACT
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDER MEDICAL SARL-NAUCHATEL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23375600
• Report Number: 3003990090-2025-01667
• Device Sequence Number: 18421644
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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
• Device Model Number: TVTRL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 10/23/2025
• 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