BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCORRECT SYSTEM

    MDR report key: 10854902 · Received November 17, 2020

    Report

    Report Number
    3007130440-2020-00006
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 17, 2020
    Manufacturer
    CLEARCORRECT
    Product Code
    NXC
    PMA / PMN Number
    K113618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CASE SHOWS NO ERRORS IN THE DIGITAL SCANS RECEIVED ON SEPTEMBER 11, 2020. ALL PROTOCOLS WERE FOLLOWED DURING THE CUT AND STAGE PROCESS. A REVIEW OF THE PRODUCTION FLOOR WAS PERFORMED WHERE IT WAS CONFIRMED THAT PROCESSES WERE BEING PERFORMED AS PROCEDURALLY REQUIRED. THE CASE DID HAVE SEVERAL REJECTIONS FOR MANUAL OVERTRIM AND WAS PRODUCED IN 4 DIFFERENT BATCHES. A REVIEW OF BATCH 212384, 212733, 211149, AND 212847 WAS PERFORMED WHERE IT WAS CONFIRMED THERE WERE NO SIMILAR COMPLAINTS, THUS THE EVENT WAS ISOLATED TO THIS CASE. ADVERSE EVENT QUESTIONS: DOES THE PATIENT HAVE A HISTORY OF DENTAL DISEASES THAT WOULD PREVENT MOVEMENT? NO. WHAT STEP WAS THE PATIENT WEARING WHEN THIS WAS FIRST OBSERVED? 3. WERE THE TRAYS RINSED BEFORE BEING SEATED? NO. WHAT HAS BEEN USED TO CLEAN THE ALIGNERS? N/A. WHAT ARE THE SIGNS AND SYMPTOMS BEING EXPRESSED? HAS THE PATIENT SEEN THEIR PRIMARY CARE PHYSICIAN OR A SPECIALIST? IF SO, WHAT WERE THE RESULTS? YES, UNKNOWN. HAS THE DEVICE BEEN MODIFIED IN ANY WAY? NO. HOW HAS THE DEVICE BEEN MODIFIED? N/A. ARE/WERE ABRASIONS PRESENT? NO. DETAILS OF ABRASIONS: N/A. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PROVIDER WHOM SUPPLIED PROVIDER SERVICES WITH FURTHER INFORMATION FROM THE PATIENT. PATIENT LISTED A NUMBER OF SYMPTOMS AND REPORTED THAT SHE NEED TO GO TO THE ER. PATIENT ALSO STATED THAT DOCTOR'S COULD NOT DETERMINE THE CAUSE OF HER SYMPTOMS. PER THE PATIENT, ONCE SHE REMOVED THE ALIGNER SHE NOTICED AN IMPROVEMENT SEVERAL MONTH LATER. CLINICAL EVALUATION: IT IS CLEAR THE PATIENT IS SUFFERING MULTI-SYSTEM DISEASE AND FAR REMOVED FROM REPORTED COMPLICATIONS OF ALIGNER THERAPY. IT WOULD SEEM THAT THE PATIENT IS MOST LIKELY SUFFERING FROM AUTOIMMUNE DISEASE. AUTOIMMUNE DISEASE HAS BOUTS OF SYMPTOMS MIXED WITH PERIODS OF IMPROVEMENT AND THE NOTED IMPROVEMENT WITH ALIGNER DISCONTINUATION COULD SIMPLY BE COINCIDENTAL WITH ONE OF THESE. NEVERTHELESS, MY RECOMMENDATION IS TO DISCONTINUE ALIGNER TREATMENT AND DEFER TO HER PHYSICIANS TO DIAGNOSE AND MANAGE HER SYMPTOMS. REGULATORY ASSESSMENT: WE DO NOT BELIEVE THAT THE DEVICE CAN BE RESPONSIBLE FOR ALL OF THE DESCRIBED SYMPTOMS BUT CANNOT STATE THAT THE DEVICE DID NOT CONTRIBUTE. THE EXTENT OF MEDICAL INTERVENTION PURSUED, ALTHOUGH INCONCLUSIVE, RAISES THIS EVENT TO THE LEVEL OF MEETING ADVERSE EVENT REPORTING CRITERIA.

    Description of Event or Problem · 1

    EMAIL FROM CUSTOMER (PROVIDER): "WE HAD DONE AN UNLIMITED PLAN WITH HER IN THE LAST YEAR PLUS. AROUND (B)(6) 2020 [PATIENT] WAS HAVING SOME HEALTH ISSUES, A LOT OF WHICH CENTERED AROUND NAUSEA. AT THAT TIME, SHE QUESTIONED WHETHER THE TRAY COULD HAVE HAD ANYTHING TO DO WITH THAT. I SPOKE WITH SUPPORT AND IT WAS CONVEYED THAT UNLESS THEY WERE TRIGGERING A GAG REFLEX OR WERE SO TIGHT THAT IT WAS MAKING HER SICK IT PROBABLY WASN'T THE TRAYS. AT THIS TIME [PATIENT] WAS GETTING SICKER AND BEGAN A SEARCH WITH HER PHYSICIANS TO FIND THE ROOT CAUSE. SHE HAS BEEN THROUGH A MYRIAD OF TESTS AND NOTHING WAS FOUND SYSTEMICALLY TO EXPLAIN THE NAUSEA AND SICKNESS. IN THE SPRING SHE HAD GOTTEN SO SICK (SHE LOST 50 LBS) THAT SHE COULD BARELY MOVE AROUND AND WAS TO A POINT WHERE SHE NEEDED A DRIVER TO TRAVEL ANYWHERE. SHE KEPT QUESTIONING THE TRAYS. I TOLD HER TO TAKE THEM OUT AND SEE WHAT HAPPENS TO RULE OUT THE TRAYS AS BEING PART OF THE PROBLEM. SHE DID THIS IN MAY AND BY JULY THE SYMPTOMS DID START TO DISSIPATE. TO THIS DAY SHE STILL HAS SOME ILL EFFECTS, ONE OF WHICH IS ITCHINESS, WHICH STARTED AT THE SAME TIME AS THE NAUSEA. PERSONALLY, I AM SKEPTICAL THAT THE TRAYS HAD ANYTHING TO DO WITH HER ISSUES. HOWEVER, THE TIMING DID COINCIDE WITH THE TRAYS. SHE AND HER FAMILY HAVE DONE A LOT OF RESEARCH AND FOUND COUNTLESS POSTS ONLINE REGARDING INVISALIGN AND VERY SIMILAR REACTIONS. I HAVE READ THROUGH ALL OF WHAT SHE BROUGHT ME AND NONE SPECIFICALLY IMPLICATED CLEAR CORRECT. ALONG WITH THOSE CASE STUDIES SHE HAD A STACK OF HER INVOICES FROM HER DIAGNOSTIC TEST TOTALING $60K+ IN INSURANCE FILINGS. THE LAST PIECE OF INFORMATION SHE BROUGHT WAS ABOUT CONTACTING THE FDA REGARDING HER REACTIONS. SHE REALLY WANTS THIS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321907 CLEARCORRECT SYSTEM CLEAR PLASTIC ORTHODONTIC ALIGNER NXC CLEARCORRECT Aligner (Single-Layer) 211149

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other