FDA Adverse Event Other Summary report: N

ORTHODONTIC ANCHOR SYSTEM

MDR report key: 1059472 · Received June 10, 2008

Report

Report Number
MW5007250
Event Type
Other
Date Received
June 10, 2008
Date of Event
June 5, 2008
Report Date
June 10, 2008
Product Code
EBI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

CONTRACTED WITH ORTHODONTIST WHO CLAIMED TO BE 1 OF 12 DOCTORS, WHO IS AUTHORIZED TO USE THE NEW ANCHOR SYSTEM RECENTLY APPROVED BY THE FDA IN THE MOVEMENT OF TEETH. RATHER THAN PATIENTS USING BRIDGES TO FILL GAPS WHERE TEETH USE TO BE, CONCEPTUALLY, THE ANCHOR SYSTEM IS USED TO MOVE THE TEETH TOWARD EACH OTHER, SO THERE IS NO LONGER ANY GAPS BETWEEN TEETH. DR ORALLY AND CONFIDENTLY CLAIMED THAT THIS ANCHOR SYSTEM WOULD MOVE MY TEETH TOGETHER PRACTICALLY PROBLEM-FREE WITHIN AN 18 MONTHS PERIOD. I HADE IT CLEAR THAT WAS ALL I COULD AFFORD. THIS PROCESS WAS BEING USED IN PLACE OF GETTING 2 BRIDGES FROM A DENTIST. HE SOLD HIMSELF AND THE PROCESS AND ONCE I AGREED TO DOING IT, UPON LEAVING THE OFFICE, HE HANDED ME THE CONTRACT AND SAID, "YOU NEED TO SIGN THAT BEFORE WE CAN BEGIN." HE NEVER ONCE WENT OVER ANYTHING IN THE CONTRACT, THUS THE CONTENT OF THE CONTRACT WAS TREATED AS SOMETHING NOT TO BE CONCERNED WITH - SOMETHING COMPLETELY SECONDARY TO HIS VERBAL CLAIMS. DR DIDN'T SEEM VERY EXPERIENCED WITH THIS SYSTEM AS THE PLACEMENT OF THE ANCHORS IN MY JAW CAUSED GREAT PAIN IN THE FIRST TWO TRANSACTIONS. ONE TIME, AS HE WAS SCREWING THE ANCHOR IN, HE SAW I WAS IN GREAT PAIN AND HIS ASSISTANT EVEN RECOMMENDED THAT HE STOP SCREWING IT IN, BUT HE CONTINUED AS IF THE PAIN WAS SOMETHING THAT WAS CUSTOMARY OR COMMON AND WOULD ONLY LAST FOR A SHORT WHILE. IT GOT GREATER AFTER THE ANCHOR WAS FULLY IN. UPON XRAYING THE PLACEMENT OF THAT PARTICULAR ANCHOR, IT WAS CLEAR HE HAD HIT A NERVE AND IMMEDIATELY NEEDED TO UNSCREW IT. HE INITIALLY, ORALLY SOLD THIS ANCHOR SYSTEM PROCESS AS A COUPLE OF ANCHORS IN MY MOUTH THAT WOULD BE PROBLEM-FREE FOR THE MOST PART. HE USED AN ILLUSTRATION ON A BROCHURE OF A COUPLE OF ANCHORS IN A MOUTH PERFECTLY PLACED AND PROBLEM-FREE. THAT WAS THE PICTURE I WAS PAINTED. REALITY WAS THE EXACT OPPOSITE. IF MY MEMORY SERVES ME RIGHT, AT TIMES THERE WERE 4 ANCHORS IN MY MOUTH EVEN THOUGH I WAS INITIALLY TOLD ALL I WOULD NEED IS A COUPLE OF THEM. THOSE ANCHORS WOULD CONSISTENTLY LOOSEN, THUS NOT STAY GROUNDED, SO HE WOULD HAVE TO SCREW NEW ONES IN ON A REGULAR BASIS. HENCE I HAD HOLES ALL OVER MY MOUTH AND ONE TIME AFTER INSERTING AN ANCHOR, MY JAW WAS RIDICULOUSLY SWOLLEN FOR ABOUT 5 DAYS. AS TIME WENT ON, THE DR SEEMED TO GET MORE CONFIDENT IN THE PLACING OF THE ANCHORS, BUT TYPICALLY THOSE ANCHORS WOULD LOOSEN AND HE WOULD HAVE TO PUT NEW ONES IN. IN THE PROCESS, THE TEETH WERE NOT MOVING AS HE FORECASTED, BUT I WAS STILL MAKING MY MONTHLY PAYMENTS. NEAR THE END OF THE 18 MONTHS, THE DR DECIDED TO USE A MUCH LONGER AND THICKER SCREW AND WAS SURE THAT IT WOULD NEVER LOOSEN. AT MY LAST APPOINTMENT - I WAS TOLD THAT IT HAD LOOSENED AND NOT BEEN EFFECTIVE AS WELL. AFTER 12 MONTHS OF USING THE ANCHOR SYSTEM THE TEETH BARELY MOVED, HENCE THE DR STARTED PLAYING A COMPLETELY DIFFERENT TUNE RELATIVE TO THE SUCCESS OF THIS PROCESS WITHIN THE INITIAL TIME FRAME. I HAVE TWO LETTERS THAT WERE WRITTEN TO HIM THAT EXPLAIN IN DETAIL WHAT WAS GOING ON. DURING THE PROCESS OF MOVING TEETH, I HAD TO GET 2 ROOT CANALS IN TWO WEEKS AND THE DR MADE SURE THAT I WENT TO A SPECIALIST. HE RECOMMENDED HIS SPECIALIST, WHOM I CALLED TWO OR THREE TIMES DURING THE PAIN OF A ROOT CANAL, BUT SHE NEVER RETURNED MY CALL. EVENTUALLY, I WENT TO A FORMER ENDODONTIST I USED A LONG TIME AGO, COSTING ME TWICE THE AMOUNT IT WOULD HAVE COST HAD I GONE TO MY DENTIST. TWO TEETH ALSO BROKE DURING THE PROCESS. ONE BROKE AS HIS ASSISTANT WAS WORKING ON MY TEETH, BUT THE DR ASSURED ME HIS TREATMENT HAD NOTHING TO DO WITH THE TEETH BREAKING. BOTH OF THOSE TEETH WILL REQUIRE CROWNS AS WELL AS THE COST OF GETTING THEM FIXED, SO THE DR COULD CONTINUE HIS PROCESS. THE DR'S INITIAL FORECAST OF 18 MONTHS TO MOVE MY TEETH COULD CLEARLY BE SEEN TO BE OFF BY AT LEAST 36 MONTHS, IF NOT MANY MORE MONTHS, RELATIVE TO THE MOVEMENT OF THE TEETH WITHIN THE 18 MONTH TIME FRAME. BECAUSE OF THE MOVEMENT OF MY TEETH AFTER 18 MONTHS, I WILL NOW NEED 3 BRIDGES INSTEAD OF THE TWO THAT I ORIGINALLY NEEDED BEFORE I STARTED THE TREATMENT WITH DR AS HE CREATED ANOTHER GAP. ADDITIONALLY, MY TEETH HAVE MOVED IN SUCH A WAY THAT MY BITE IS NOW OFF - THE TEETH ON ONE SIDE OF MY MOUTH DO NOT TOUCH. IT HAS BEEN ONE PAINFUL NIGHTMARE - I DIDN'T REALLY GET INTO THE PAIN OF THE PROCESS - AND INSTEAD OF COSTING ME, WHICH I TOLD THE DR NUMEROUS TIMES WAS ALL I COULD AFFORD, WHEN ALL IS SAID AND DONE WITH GETTING DISCOUNT BRIDGES AT MY DISCOUNT DENTIST, DISCOUNT CROWNS, TEETH REPAIR AND ROOT CANALS I STARTED ALL OF THIS, AND MUCH MORE, ASKING THE DR IF HE WOULD GIVE ME MY MONEY BACK SO THAT I CAN PUT IT TOWARD GETTING SOME BRIDGES OR THAT HE WOULD FINISH HIS PAINFUL PROCESS WITH NO EXTRA CHARGE AND IT WAS MET WITH NO MERCY OR ACCOUNTABILITY TOWARD HIS ACTIONS. AS IF HE WEREN'T WRONG ON ANY COUNTS. IN FOLLOWING, MY EXPERIENCE OF USING THE FDA APPROVED ANCHOR SYSTEM HAS BEEN ONE THAT CLEARLY IS A FRAUD. IT EITHER DOES NOT WORK, OR THE DOCTORS WHO ARE LICENSED TO ADMINISTER THE PROCESS ARE UNQUALIFIED TO DO SO. AS A RESULT, PATIENTS LIKE MYSELF CLEARLY BECOME GUINEA PIGS WHO ARE ALSO RESPONSIBLE FOR FOOTING THE BILL OF INCOMPETENT DOCTORS. AS EXPLAINED IN DETAIL TO DR, I CANNOT AFFORD THIS CRUSHING FINANCIAL BLOW AS IT TAKES ALL OF THE MONEY I NEED TO RUN MY MINISTRY/BUSINESS OVER THE NEXT TWO YEARS. THE DOCTOR USED BRACES AND ANCHORS TO MOVE MY TEETH. I WAS ADMINISTERED TREATMENT EVERY 3 TO 4 WEEKS FOR AN 18 MONTH PERIOD. DOSE OR AMOUNT: 18 MONTHS. ROUTE: PO. DATES OF USE: 2006 -2008 (18 MONTHS). DIAGNOSIS OR REASON FOR USE: TO MOVE TEETH TOGETHER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ORTHODONTIC ANCHOR SYSTEM ORTHODONTIC ANCHOR SYSTEM EBI

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other