MAUDE Adverse Event Report: CALDERA MEDICAL TVT EXACT RETROPUBIC SYSTEM; TVTRL

Catalog Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Dysuria (2684); Urinary Incontinence (4572)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing and the results will be reported when aviable.The manufacturing number is (b)(4).
Event or Problem Description
Caldera medical received an email: this incident concerns a 68 years old patient who underwent implantation of this device on (b)(6) 2023.A urethral erosion of the sling was diagnosed requiring surgical removal on (b)(6) 2026.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Common Device Name: TVTRL
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• Manufacturer (Section G): CALDERA MEDICAL SARL NAUCHTEL; 43puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 24460842
• Report Number: 3003990090-2026-02039
• Device Sequence Number: 15779006
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: TVTRL
• Device Lot Number: 3943706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/26/2026
• 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 Age: 68 YR
• Patient Sex: Female