Description of Event or Problem · 1
I PURCHASED A 24-ALIGNER KIT FROM SMILEDIRECTCLUB.COM. THE 8TH ALIGNER IN THE SERIES (BOTTOM PIECE) DID NOT ADHERE TO THE TEETH CORRECTLY. IN RESPONSE TO MY REQUEST FOR A REMEDY (ON (B)(6) 2019), I WAS SENT A COMPLETE SET OF 24 NEW ALIGNERS (ARRIVING (B)(6) 2020). THE ALIGNER #8 FROM THAT SET WAS FINE. FOR ALIGNER #9, I TRIED TO GO BACK TO THE ORIGINAL SET, BUT IT ALSO FIT POORLY. RETURNING TO THE SECOND SET, I MADE IT ALL THE WAY TO ALIGNER #11 (ON (B)(6) 2020). WHEN I OPENED THE ALIGNER #11 PACKET, I FOUND IT CONTAINED TWO BOTTOMS (INSTEAD OF A BOTTOM AND A TOP). BOTH PIECES WERE MARKED IDENTICALLY, AND THERE WAS NO WAY TO TELL WHICH ONE MIGHT ACTUALLY BE NEXT IN THE SERIES. I CHECKED THE ALIGNER #12 PACKET AND FOUND THAT THIS ONE HAD TWO TOPS, ALSO MARKED IDENTICALLY, AND WITH NO WAY TO DISTINGUISH THEM. THEN I CHECKED THE ALIGNER #13 PACKET. IN THIS ONE, WHILE THERE WAS BOTH A TOP AND A BOTTOM, ONE OF THE TOOTH POCKETS HAD AN OBVIOUS DEFECT IN THE PLASTIC, AND THERE WAS NO WAY IT WOULD FIT PROPERLY OVER MY TEETH. I HAVE SUBSTANTIAL DOUBTS THAT I WILL BE ABLE TO COBBLE TOGETHER A PROPER SERIES OF 24 ALIGNERS, EVEN THOUGH I OWN TWO COMPLETE AND INDEPENDENT SETS. THE QUALITY LEVEL OF THIS PRODUCT IS OUTSIDE WHAT A CONSUMER SHOULD EXPECT FOR A SAFE, PRECISION TOOTH ALIGNER. THE CONSIDERABLE PRODUCTION DELAYS SUGGEST TO ME THAT SMILEDIRECTCLUB'S QUALITY CONTROL IS UNDER PRESSURE. IN ADDITION, SMILEDIRECTCLUB HAS NOT CONTACTED ME WITH INSTRUCTIONS ON HOW TO SUPPLY 90-DAY PERIODIC CHECK-IN PHOTOS (NEEDED TO MAINTAIN THEIR WARRANTY), ALTHOUGH I HAVE NOT ADDRESSED THE ISSUE WITH THEM. AS SUCH, I HAVE NOT SENT ANY PHOTOS TO THEM IN RELATION TO THE 90- DAY CHECKS, EVEN THOUGH I BEGAN TREATMENT ON (B)(6) 2019. FDA SAFETY REPORT ID# (B)(4).