[3960783]
The pt had a dental crown cemented which later came off. Below is an excerpt from an email to the manufacturer describing the problem with their product: the first crown that we bonded was for pt (b)(6) on (b)(6) 2012. His crown was also the first one that de-bonded. When we used the proprietary cement for this first case (as we did on all cases for this product) i spoke to the local manufacturer's rep in my office about the steps in the bonding procedure. She walked through it with me and gave me the printed instructions for the product. As with all new products that do not have identical steps as an existing product we are using, i took the time to review the steps with my dental assistant with the printed instructions. Since there are many more steps involved than with the resin-modified glass ionomer cement that we were accustomed to using, we actually laid out the printed instructions on the counter top in the operatory during the crown seat appointment for pt ge to insure proper protocol was used. When ge's crown came off during a routine cleaning appointment (b)(6) 2013, it was re-cemented with the same product, using the same instructions. This initial incident was not reported to the local rep or to any members of the dental lab team. It seemed like there could have been reasonable causes for the failure including some error with first-time use, minimal retention due to very short clinical crown height, or even the possibility that the adhesive resin wasn't bonding to the build-up that had not been removed at the time of the prep. It was not until the second crown de-bonded on pt (b)(6) on (b)(6) 2013 that i contacted the lab to let them know. (b)(6) original crown seat was on (b)(6) 2013 and at that point there was no concern with retention or with experience in using the cement. Her crown was re-cemented with the same product, using the same instructions. Following this second failure i spoke with the local manufacturer's rep and she suggested i try light-curing the bonding agent on the tooth prior to seating the crowns in the future (she also suggested that in step 7, if the bonding agent was not "rubbed in" or if it was rubbed, but for 19 seconds instead of 20, then the crown may de-bond). Since then we have been using the suggested instructions and we did received a new set of printed instructions in the late spring with two additional steps that were not on the original instructions. Even with this new method, the crown on pt ts and the second crown on pt (b)(6) still came off. Listed below are the pts that have had these crowns de-bond, the original seat date, the date of de-bond, and the circumstances under which the failure occurred. (b)(6): (b)(6) 2012 - (b)(6) 2013. Crown came off during routine cleaning. (b)(6): (b)(6) 2013. Crown came off while eating. (b)(6): (b)(6) 2013. Crown came off while eating cheesy bread. Pt bit down on de-bonded crown and broke it. New crown of the same material was fabricated. See below. (b)(6): (b)(6) 2013. Crown came off eating pasta. (b)(6): (b)(6) 2013. Crown came off during restoration of access prep from root canal therapy. (b)(6): (b)(6) 2013. Crown came off while eating fried rice. I have cemented 55 crowns of this material. That's a (b)(4) failure (in a very short period of time) and prior to this my failure rate for all other materials was 0%. All printed manufacturer instructions were followed, suggestions from the local rep were followed, the manufacturer changed the printed directions midway through my experience with this product and the new instructions with the additional steps were followed, but still the product failed. Due to the high failure rate and the risk of aspiration, swallowing, and/or tooth damage, this product is no longer used in my office. Dates of use: (b)(6) 2012 - (b)(6) 2013. (b)(4).
Patient Sequence No: 1, Text Type: D, B5