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Table 20 Complications and/or side effects as described in the MAUDE database

From: The NTI-tss device for the therapy of bruxism, temporomandibular disorders, and headache – Where do we stand? A qualitative systematic review of the literature

Web link Year Complaints/Side effects
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=471018 2003 "This device [...] will not stop migraines, it took out pt's two front crown teeth, it causes tooth movement, joint strain [...]. This device is harmful – dangerous and it is not therapeutic. Pt had to have surgery to undo the harm that was caused by the nti splint"
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=551955 2004 "[...] the device was not only ineffective, but has done damage to their jaw alignment, bite, and facial appearance. The device caused them to grind their front teeth instead of their molars. Even though rptr only wore it for two weeks, rptr's jaw and their bite has not returned to "normal". During the two weeks rptr wore it, rptr suffered extreme headaches, facial pain, and their front teeth loosened. [...] Rptr's teeth are actually moving position since rptr can barely bite down without forcing their lower jaw back. Their front teeth are shifting back because they are constantly pushing against their upper teeth. Eating and chewing is challenging since they can't actually touch their upper and lower molars together without effort. Therefore, rptr's lower jaw spasms when they chew."
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=557167 2004 "Pt's concern is that this device poses a significant threat of death by choking. [...] A user could dislodge the nti-tss with the tongue, or, during sleep, unconsciously reach into the mouth to loosen or readjust it it is very uncomfortable-. If it remained in the mouth it could easily become lodged in the throat."
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=753670 2006 "Since the implant was put in, patient has been having migraine headaches and a clicking jaw. [...] Her teeth have moved so much that according to the dentist, she would need braces to move her teeth to position. Patient never had a history of migraine."
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.cfm?MDRFOI__ID=765535 2006 "Not only is his new apparatus devoid of a safety device to keep him from swallowing it in his sleep, but (1) it fit very tightly and (2) it was very difficult to remove. When he did take out the device, it felt as if he was going to pull his teeth out. Last night, when he went to sleep, he was awakened when the device broke in his mouth."