Description of Event or Problem · 1
I COMPLETED A 6 MONTH AT-HOME ORTHODONTIC WITH SMILE DIRECT CLUB FROM (B)(6) 2019 - (B)(6) 2019. PRIOR TO STARTING TREATMENT, MY BITE WAS ABLE TO FULLY CLOSE. THROUGHOUT THE TREATMENT, I NOTICED ISSUES WITH MY BITE NOT CLOSING FULLY. I EXPRESSED THIS CONCERN WITH PHOTOS DURING AN ONLINE CHECK IN AT THE 90-DAY MARK AND WAS TOLD THAT MY TEETH WERE MOVING AND MY BITE WOULD COME BACK TOGETHER. ABOUT A MONTH BEFORE TREATMENT WAS SUPPOSED TO END, I REACHED OUT AGAIN VIA PHONE / VOICEMAIL TO AGAIN EXPRESS CONCERN THAT MY OPEN BITE DID NOT SEEM TO BE COMING BACK TOGETHER BUT RATHER GETTING WORSE / BECOMING MORE OPEN. I DID NOT GET A RETURN CALL FROM THE DENTAL TEAM. FINALLY I MY FINAL WEEK OF TREATMENT, I REACHED OUT VIA EMAIL EXPRESSING CONCERNING ABOUT MY BITE AND DEMANDING SUPPORT. THE DENTAL TEAM RESPONDED AND ASKED FOR A SERIES OF PHOTOS TO ASSESS THE ISSUE, TO WHICH I COMPLIED. AFTER MANY DAYS OF HEARING NOTHING BACK AND SENDING F/U EMAILS, THE SMILE DIRECT CLUB TEAM RESPONDED SAYING THEY SEE THE ISSUE I WAS DESCRIBING AND WOULD OFFER ADD'L TREATMENT TO FIX THE OPEN BITE THEY CAUSED AT NO ADD'L COST. AT THAT POINT, I DID NOT TRUST THEIR TREATMENT AND DECLINED THE OFFER FOR ADD'L TREATMENT BUT REQUESTED A REFUND IN FULL. I WILL NOW NEED TO PAY FOR ADD'L ORTHODONTURE TO FIX MY OPEN BITE TO ALLOW ME TO EAT PROPERLY, A COST AND TIME OF TREATMENT WHICH WOULD NOT HAVE HAD TO ENDURE WOULD IT NOT HAD BEEN FOR SMILE DIRECT CLUB TREATMENT. I BELIEVE THAT SMILE DIRECT CLUB IS HARMING PTS AND NOT COMPLYING WITH PROPER DENTAL / ORTHODONTURE CARE. I HAD SCANS AND PHOTOS PRIOR TO MY SMILE DIRECT CLUB TREATMENT (BY SMILE DIRECT CLUB ON (B)(6) 2019 AND BY (B)(6) ON (B)(6) 2019) AND FOLLOWING MY SMILE DIRECT CLUB TREATMENT (BY (B)(6) ON (B)(6) 2019 AND (B)(6) ON (B)(6) 2019) WHICH SHOW THE PROGRESSION / CAUSE OF MY OPEN BITE DUE TO SMILE DIRECT CLUB TREATMENT. I'D BE HAPPY TO SHARE THOSE PHOTOGRAPHS / RESULTS. FDA SAFETY REPORT ID# (B)(4). SEE SCANNED PAGES.