BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN

    MDR report key: 3453258 · Received November 1, 2013

    Report

    Report Number
    MW5032551
    Event Type
    Injury
    Date Received
    November 1, 2013
    Report Date
    October 31, 2013
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEGAN INVISALIGN TREATMENT (B)(6) 2012. NOTICED STOMACH GURGLING, MAINLY AT NIGHT WHEN LYING DOWN IN (B)(6) 2012. REPORTED ISSUE TO ORTHODONTIST AT FOLLOW UP APPOINTMENT (B)(6) 2012. HE STATED THAT INVISALIGN COULD CAUSE STOMACH GURGLING TUE TO EXCESS SALIVA THAT IS PRODUCED AND SWALLOWED, BUT SAID THE PROBLEM SHOULD SUBSIDE IN ABOUT THREE MONTHS ONCE THE BODY GETS USED TO THE APPLIANCE. ON (B)(6) 2012, CONTACTED THE MAKER OF INVISALIGN, ALIGN TECHNOLOGY, INC. SPOKE WITH EXON ABOUT STOMACH GURGLING ISSUE. HE SAID IT WAS AN UNUSUAL SYMPTOM AND THAT I SHOULD HAVE MY ORTHODONTIST REPORT IT TO THEM SO THAT AN OFFICIAL INQUIRY COULD TAKE PLACE. RELAYED MESSAGE TO ORTHODONTIST (B)(6) 2012. ACCORDING TO RECEPTIONIST, HE REPORTED ISSUE. SAW FAMILY PHYSICIAN (B)(6) 2012 ABOUT ISSUE. BLOOD WORK AND PHYSICAL EXAM NEGATIVE. PROBLEM ATTRIBUTED TO INVISALIGN AND EXCESS SALIVA, AND POSSIBLY VEGETARIAN DIET. SHE RECOMMENDED BEANO. TRIED SIMILAR PRODUCT CALLED PEACEFUL DIGESTION. NO IMPROVEMENT. REPORTED NEW SYMPTOM TO ORTHODONTIST (B)(6) 2012 AT FOLLOW UP APPOINTMENT (PAINLESS JAW CLOCKING NOTICED (B)(6) 2012). WAS TOLD TO LET HIM KNOW IF IT BEGINS TO HURT. NEW TRAYS MADE (B)(6) 2013. OLD TRAYS DID NOT FIT OVER ALL TEETH. EXPECTED RESULTS NOT ACHIEVED. SAW PRIMARY CARE PHYSICIAN ON (B)(6) 2013 FOR CONTINUED STOMACH GURGLING. BLOOD WORK NEGATIVE, BUT INCREASED BOWEL SOUNDS HEARD WITH STETHOSCOPE. DISCONTINUED INVISALIGN PER HER ADVICE TO SEE IF SYMPTOMS IMPROVED. THEY DID NOT. REFERRED TO GASTROENTEROLOGIST. DID NOT RECOMMEND SCOPE AT TIME. TOLD TO LET HIM KNOW IF ADDITIONAL SYMPTOMS OCCUR, THEN WILL RE-EVALUATE DECISION TO SCOPE. SIGNIFICANT SYMPTOM IMPROVEMENT NOTICED (B)(6) 2013. DEVELOPED FACE/JAW PAIN (B)(6) 2013. REPORTED TO ORTHODONTIST (B)(6) 2013. REFERRED TO ORAL SURGEON. PRESCRIBED NAPROXEN AND REFERRED TO PHYSICAL THERAPIST FOR INTERNAL DERANGEMENT. HAD PHYSICAL THERAPY FOR ONE MONTH WITH EXERCISE, ELECTRICAL STIMULATION, AND ULTRASOUND. PAIN IMPROVED. WAS RELEASED TO DO HOME EXERCISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563333 INVISALIGN INVISALIGN NXC ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention