TVT EXACT RETROPUBIC SYSTEM
Report
- Report Number
- 3003990090-2025-01712
- Event Type
- Malfunction
- Date Received
- November 4, 2025
- Date of Event
- October 28, 2025
- Report Date
- January 12, 2026
- Manufacturer
- CALDERA MEDICAL INC.
- Product Code
- OTN
- PMA / PMN Number
- K132054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR PART 803. THE INFORMATION CONTAINED HEREIN IS BASED ON DATA AVAILABLE TO CALDERA MEDICAL AT THE TIME OF SUBMISSION AND MAY NOT HAVE BEEN FULLY INVESTIGATED OR INDEPENDENTLY VERIFIED PRIOR TO THE REQUIRED REPORTING DEADLINE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR CONCLUSION BY CALDERA MEDICAL THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION REMAINS ONGOING. IN ACCORDANCE WITH MANUFACTURING PROCEDURES, TRAYS ARE INSPECTED AGAINST A BLACK BACKGROUND, AND NO PARTICLES WERE NOTED DURING THESE INSPECTIONS. A FINAL INSPECTION OF THE PRODUCT IS ALSO PERFORMED TO VERIFY PRODUCT INTEGRITY. ALL MESH DEVICES WERE STERILIZED USING ETHYLENE OXIDE, AND THE PRODUCTS WERE CONFIRMED TO MEET SPECIFICATIONS AT THE TIME OF RELEASE. A REVIEW OF THE MANUFACTURING RECORDS INDICATES THAT ALL PRODUCTS RELEASED DURING THE RELEVANT TIMEFRAME WERE MANUFACTURED IN ACCORDANCE WITH APPROVED PROCEDURES AND MET ALL ESTABLISHED SPECIFICATIONS DURING BOTH MANUFACTURING AND QUALITY RELEASE PROCESSES. AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE REPORTED EVENT AT THIS TIME. THE INVESTIGATION WILL CONTINUE, AND THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE MANUFACTURING NUMBER IS (B)(4).
ADDITIONAL INFORMATION: D5, D9, H3, H6, H11. INVESTIGATION RESULTS: THE NEUCHÂTEL TEAM RECEIVED THREE PHOTOS FOR EVALUATION OF THE TVT EXACT PRODUCT, PRODUCT CODE TVTRL AND BATCH NUMBER 3945035. AN INVESTIGATION WAS CONDUCTED ON THE PHOTOS RECEIVED AND ON THE BATCH FILE. THE IDENTIFICATION LABELS STUCK ON THE BOXES CORRESPOND TO THE BATCH OF THE COMPLAINT. DURING THE EVALUATION OF THE PHOTO, THE PRESENCE OF WHITE PARTICLES IS OBSERVED IN THE PRIMARY PACKAGING. NO PARTICLE SIZE MEASUREMENTS CAN BE PERFORMED ON PHOTOS . ACCORDING TO THE EVALUATION, THIS COMPLAINT IS RELATED TO A MANUFACTURING ISSUE. THE DEFECT OBSERVED DURING THE EVALUATION CORRESPONDS TO THE DESCRIPTION OF THE EVENT: (FOR WHITE POWDER INSIDE THE PACKAGING). THE COMPLAINT IS CONFIRMED AND IS RELATED TO MANUFACTURING (CLASS I DEFECT AS PER WI-EMQD10 REV.25). THE POWDER HAS BEEN CONFIRMED TO BE FROM THE UNDERSIDE OF THE TYVEK ADHESIVE - POWDER IS CREATED DURING TRANSIT WHEN DEVICE/PACKAGING IS CONTACTING UNDERSIDE OF THE TYVEK MATERIAL ALL MATERIALS USED IN THESE DEVICES AND PACKAGING MEET THE BIOCOMPATIBILITY REQUIREMENTS CONTAINED IN ISO 10993-I: "BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING" AND ON FDA GENERAL PROGRAM MEMORANDUM #G95-I: USE OF INTERNATIONAL STANDARD ISO - 10993, "BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING." THE WHITE POWDER HAS BEEN TESTED BY A THIRD-PARTY LABORATORY FOR POTENTIAL CYTOTOXICITY CONCERNS. IT HAS BEEN DETERMINED THAT THE POTENTIAL DEPOSITION OF THESE PARTICLES INTO THE PATIENT WOULD NOT SIGNIFICANTLY INCREASE THE RISK OF TOXICITY. THE MANUFACTURING NUMBER IS (B)(4).
IT WAS REPORTED THAT 5 TVT EXACTS WITH WHITE DUST WERE IDENTIFIED AND RETURNED. TVTRL LOT # 3945035.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2693472 | TVT EXACT RETROPUBIC SYSTEM | TVT-CAL-EXACT | OTN | CALDERA MEDICAL INC. | TVTRL | 3944947 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |