Description of Event or Problem · 0
REPORTING ANONYMOUSLY /MY ENGLISH NOT VERY WELL, I AM A PROUD AMERICAN CITIZEN SINCE 2012. I WILL SEND AN EMAIL [email protected]., WITH THE EVIDENCE THAT I HAVE DOCUMENTED FAILED TO REPORT SAFETY ISSUE/HIDDEN SAFETY ISSUE WITH MRI , DISGUISING THE PUBLIC AND COSTUMERS, FOR FAILING TO POST ON THE WEBSITE REAL DATA CONCERNING SAFETY HEALTH ISSUE AND PRETENDING FOR 7 YEARS WITH USING FALSELY/ILLEGALLY THE LOGO OF FDA FROM 2017-2024 TO PROMOTING THEY BAND UNLAWFULLY USING THE US GOVERNMENTAL OFFICIAL LOGO, ENGAGE ALSO ON UNLAWFULLY COMMERCIAL PRACTICES, TOWARD OTHER DENTAL IMPLANTOLOGY BRAND/COMPANIES. ENDANGER THE PUBLIC HEALTH SAFETY, AFFECTING ESPECIALLY VULNERABLE INDIVIDUALS, ELDERLY. ALSO THE STATEMENT OF THEIR LOGO ¿JUST SMILE¿ IS MISLEADING (TO ATTRACT CONSUMERS) BECAUSE THOSE IMPLANT DON`T REFLECT THE SMILE (FOR EXAMPLE MY CASE-I AM WITHOUT TEETH FOR 3 MONTHS) AS THE DENTAL PROTHESIS LOOK HORRIBLE NONAESTHETIC, AS THE DENTIST FAILED TO KEEP HIS PROMISES. I COULDN`T SMILE/MY SMILE IS HORRIBLE, AND NOT WHAT THIS COMPANY PREACH. EVEN MORE STRANGELY FDA ISSUE STATEMENT ON SAFETY IN 28-AUG-2024 MEDICAL DEVICE REPORTING (MDR): HOW TO REPORT MEDICAL DEVICE PROBLEMS / FDA, AFTER 16-AUG-2025. THE PROBLEM IS THE PUBLIC IS NOT AWARE OF THE TRUTH. FROM 2015-2017 THEY WERE STRANGELY APPROVED BY FDA IN 2015, AFTER THE NONCOMPLIANCE REQUIREMENT WAS EXPOSED, THEY WERE TRYING FOR 7 YEARS TO GET BACK IN THE US MARKET, BY CHEATING THE SYSTEM, USING UNLAWFUL TACTICS TO GAIN PUBLIC AND CORPORATIONS TRUST. FDA - AUGUST 16, 2024 - K233896 - EXPIRATION DATE: 07/31/2026 ¿ JDEVOLUTION K233896.PDF. FDA-OCTOBER 11, 2024 - K240143 ¿ EXPIRATION DATE: 07/31/2026 ¿ JDZYGOMA K240143.PDF. IMMEDIATELY AFTER APPROVAL BY FDA, SHOWING UP ON JDENTALCARE SRL WEBSITE A NEW REGULATION OF NOV 2024, BUT POSTED TO THE PUBLIC ONLY ON 04-MAR-2025, THE WARNING ABOUT MRI PATIENT INJURY. THEY FAILED TO DISCLOSE SAFETY ISSUE OF MRI, TO THE FDA AND TO THE PUBLIC, CLAIMING THEY WAS INSTRUCTED BY FDA. IN JDZYGOMA APPLICATION K240143.PDF THEY FAILURE ENTIRELY TO MENTION ABOUT THIS ISSUE, EVEN IF ON THEY WEBSITE WAS CHANGED ON SAFETY ISSUE WITH MRI 3 TIMES! (2 ON THE IFU/EIFU JDEVOLUTION+ 1 IFU/EIFU JDZYGOMA, THEY DON`T HAVE ANY TESTS ON IT AND GO BY STORIES FOUND ON THE INTERNET: ¿MRI ENVIRONMENT NON-CLINICAL WORST-CASE MRI REVIEW WAS PERFORMED TO EVALUATE THE JDENTALCARE IMPLANT SYSTEM DEVICES IN THE MRI ENVIRONMENT USING SCIENTIFIC RATIONALE AND PUBLISHED LITERATURE, BASED ON THE ENTIRE SYSTEM INCLUDING ALL VARIATIONS (ALL COMPATIBLE IMPLANT BODIES, DENTAL ABUTMENTS, AND FIXATION SCREWS) AND MATERIAL COMPOSITION. RATIONALE ADDRESSED PARAMETERS PER THE FDA GUIDANCE ¿TESTING AND LABELING MEDICAL DEVICES FOR SAFETY IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT,¿ INCLUDING MAGNETICALLY INDUCED DISPLACEMENT FORCE AND TORQUE.¿ SEEMS LIKE (B)(6) ASSISTANT DIRECTOR K240143 (APPROVED 11-OCT-2024) LIVING IN A VIRTUAL WORLD. SEEMS LIKE (B)(6) K233896 (APPROVED 16-AUG-2024) IS IN CONFLICT OF INTEREST ON THESE 2 SEPARATE CASES APPARENTLY SINCE NOV 6, 2015 WHEN IT WAS FIRST APPROVED BY FDA EVEN IF DOESNT HAVE THE TESTING REQUIREMENTS COMPLETED: ¿BASED ON TECHNOLOGICAL CHARACTERISTICS (INTENDED USE, MATERIAL USED, DIMENSIONS AND FEATURES) AND PERFORMANCE DATA (MECHANICAL TESTS, BIOCOMPATIBILITY TESTS, STERILIZATION AND SHELF LIFE) INCLUDED IN THIS SUBMISSION, THE JDENTALCARE® ¿, ON THEY WEBSITE SHOWING A PATTERN OF PRACTICES OF UNKNOWN MR ENVIRONMENTAL (WITH OUT TESTING) UNTIL 2024 , DENTAL IMPLANTOLOGY WAS MOVE FROM ¿REAL WORLD¿ TO ¿VIRTUAL¿ TESTING COLLECTED FROM INTERNET DATA, AS PEOPLE RECEIVING THOSE IMPLANTS ARE STILL ALIVE (AND NOT ¿VIRTUAL¿ INDIVIDUALS) THIS IS A SAFETY ISSUE IN REAL WORLD. NOW I AM SCARED EVEN TO HAVE AN MRI. AS NOBODY TELLS THE TRUTH TO REAL PATIENTS/PEOPLE STILL FROM 2017, THEY DON`T HAVE ANY APPROVAL UNTIL AUG 2024 AND OCT 2024 , STILL THEY PRESENT FALSE APPROVAL FROM FDA (7 YEARS THEY MISLEADING THE PUBLIC, PLACING PATIENTS AT RISK) FIGURING OUT AFTER SEVERAL ATTEMPTS HOW TO ESCAPE THE SYSTEM OF COMPLIANCE BY DIVERTING THE COMPLIANCE WITH CLAIMS LIKE FDA INSTRUCTIONS BASE IT ON INTERNET DATA/NOR THE REAL PRACTICAL TESTING . SEEMS LIKE IN 7 YEARS EVEN IF THEY HAVE SEVERAL CHANCES TO TEST THOSE DENTAL IMPLANTS ON MRI ENVIRONMENT, BUT FAILURE TO/OR WORST THE DEVICES FAILING THE TESTINGS! SHOWING UP WITH STORIES, TO EVADE THE COMPLIANCE REQUIREMENTS. OR EVEN WORSE, SOMEONE WAS INJURED FOR REAL, AND THEY HID THE TRUTH. AND TO GETTING WORSE, RIGHT AWAY AFTER THE FDA APPROVAL IN AUG 2024 (BASED ON THEIR BOGUS STORIES) AND NOV2024 (WITH PROVIDING NOTHING!), THEY ESCAPE BY FAILING TO REPORT THE MRI ISSUE THE SECOND TIME IN NOV2024 (ACCORDING TO THEIR ISU REVISION POSTED ONLY ON MAR2025), BUT IN THE SAME TIME SEEMS OBVIOUSLY SUSPICIOUS HOW THE SAME FDA EMPLOYEE (B)(6) WAS HANDLING THE 2 DIFFERENT APPLICATIONS FILED ON DIFFERENT DATES! (CONFLICT OF INTEREST) AND JDENTAL CARE SRL UNKNOWLEDGE THE HELP WITH INSTRUCTIONS FORM FDA (WHICH UNTIL THIS DATE WAS UNDER COMPLIANCE CONTROL) ON NOV 07,2024 EVBOX03_N REV.01 OF 2024-11-07 -POSTED: REVISION EVBOX03_N / REV. EVBOX03_N_REV01 -03/04/2025 (FILE SIZE: 2,42 MB) AND FEB 07, 2025- EVBOX03_N REV.02 OF 2025-02-07-POSTED REVISION EVBOX03_N / REV. EVBOX03_N_REV02 - 03/04/2025 (FILE SIZE: 2,55 MB) ¿ JDENTAL CARE PLACE THIS WARNING (UP TO WHAT PREVIOUSLY POSTED, RESPECTIVE:¿ SCANNING A PATIENT WHO HAS THIS DEVICE MAY RESULT IN PATIENT INJURY¿/ ¿MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION JDENTALCARE IMPLANTS HAVE NOT BEEN EVALUATED FOR SAFETY AND COMPATIBILITY IN MR ENVIRONMENT. THEY HAVE NOT BEEN TESTING FOR HEATING, MIGRATION, OR IMAGE ARTIFACT IN MR ENVIRONMENT. THE SAFETY OF JDENTALCARE IN MR ENVIRONMENT IN UNKNOWN. SCANNING A PATIENT WHO HAS THIS DEVICE MAY RESULT IN PATIENT INJURY¿, WHICH OBVIOUSLY WAS A FAILURE TO REPORT TO FDA (2 TIMES: 07-NOV-2024 AND 07-FEB-2025) + JDZYGOMA THE 3 TIME SINCE JAN2025, ON THE EIFU -23 JDZYGOMA PRODUCTS (THE 2018 CATALOG THE EIFU STATED ON JAN2025, IS THE SAME LIKE EIFU JDEVOLUTION, , BEFORE APPROVAL, EVERYTHING IS THE SAME. OBVIOUSLY, THEY ARE MISLEADING AND DISGUISING THE PUBLIC FROM 2017 (EXPIRATION DATE OF THE FIRST APPROVAL) -UNTIL AUG 2024-THE SECOND APPROVAL. WE DON¿T KNOW WHAT WAS GOING ON AS I COULDN¿T KNOW HOW TO REPORT THEM, BECAUSE MY 4 DENTAL ABUTMENTS INFO AND UDI WERE MISSING AND I REALLY DON¿T KNOW WHAT THEY ARE PLACING IN MY MOUTH. I HAVE CAPS OVER THE IMPLANTS (FROM 3 MONTH ALREADY, WHICH HAVE A VERY HEAVY METAL TASTE) BECAUSE THE ITALIAN DENTIST REFUSES TO FIX THE PROBLEM WITH THE GUM AND WITH THE DENTAL FIX PROTHESIS ALL ON 4 (4 IMPLANTS), AFTER MAKING FALSE PROMISES. I WENT TO OTHER DENTISTS TO FIX THE GUM (IN FACT I WENT TO 6 TO MAKE SURE THEY ARE CORRECT) BUT THE ITALIAN DENTIST EVEN STOLE MY PAID OFF MEDICAL DEVISE/DENTAL PROTHESES/CUSTOM MADE MEDICAL DEVISE. THE BIG ISSUE WITH THIS DENTAL PROTHESIS IS THAT VERY LITTLE DENTISTS HANDLE IT ON THESE DENTAL BOGUS IMPLANTS, AND THE PATIENTS ARE STUCK WITH THIS CRAP DENTAL IMPLANTS, AS FINDING SOME OTHER DENTIST WITH THE SAME TOOLS TO FIX IT IS ALMOST IMPOSSIBLE. THIS IS A VERY BIG ISSUE WITH THOSE UNCOMMON/UNPOPULAR IMPLANTS (EXP. JDENTAL CARE SRL), THERE SHOULD BE MANDATORY ON THE DENTIST¿S WEBSITE A LIST WITH ALL THE IMPLANTOLOGY DENTAL IMPLANTS COMPANIES THEY ARE USING, AS PEOPLE SHOULD/MUST/COULD KNOW TO BE ABLE TO MAKE AN INFORMAL DECISION + INFORMAL CONSENT BEFORE ENTER IN A TRANSACTION WITH SUCH A HUGE FINANCIAL IMPACT. JDENTAL CARE SRL, GAIN ENTRANCE IN US MARKET BY CHEATING, ERODING PUBLIC TRUST, ALSO THEY WEBSITE HAS EXTREMELY/VICIOUSLY HIDDEN INFO TO THE PUBLIC IN VIOLATION OF ART 18 REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5-APRIL-2017.