SMILEDIRECTCLUB CUSTOM FABRICATED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-01 for SMILEDIRECTCLUB CUSTOM FABRICATED manufactured by Smiledirectclub, Llc.

Event Text Entries

[126219376] Subjective pt pursued smiledirect invisible aligners for mandibular crowding starting in (b)(6) 2017. In (b)(6) 2017 her left jaw locked closed for 3 days in a row, and she noticed much worse jaw symptoms. She reached out to smiledirect and they recommended seeing a tmj specialist or to email with one of their drs. She visited an urgent care in (b)(6) 2017, was told she had no jaw fractures, and was prescribed a muscle relaxer which didn't help as much as the ibuprofen 800mg q8h x1wk. She described a constant, moderate, aching baseline pain, with moderate to severe, aching, pressure, throbbing pain in her jaw bilaterally [pointing to preauricular and ramus/masseter areas], with occasional ear aches. Her symptoms are worse with hard/chewy food, yawning, rainy/cold weather, chewing gum, clenching/bracing, concentrating on a task, opening wide, and sleeping on her hands which puts pressure on her jaw. Her symptoms are better with soft food, warm compresses only briefly, sleeping on her back or side, and ibuprofen. Assessment myofascial pain and referral bilateral tmj arthralgia left tmj disc displacement with reduction with intermittent lock right tmj disc displacement with reduction. Objective im joints. Mandibular range of motion was grossly intact with mild to moderate tmj and masseter pain on maximal opening and excursive movements, replicated cc auscultation revealed bilateral click palpitation revealed moderate to severe bilateral pain, familiar, musculoskeletal: mild tenderness to palpation of the temporalis muscles, familiar headache, severe tenderness to palpation of the masseter muscles, active pain referral, replicated cc severe tenderness to palpation of the upper quarter muscles, active pain referral, familiar mild to moderate forward head posture.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081003
MDR Report Key8032500
Date Received2018-11-01
Date of Report2018-10-30
Date of Event2017-11-01
Date Added to Maude2018-11-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSMILEDIRECTCLUB
Generic NamePOSITIONER TOOTH, PREFORMED
Product CodeKMY
Date Received2018-11-01
Model NumberCUSTOM FABRICATED
Catalog NumberCUSTOM FABRICATED
Lot NumberCUSTOM FABRICATED
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSMILEDIRECTCLUB, LLC
Manufacturer AddressNASHVILLE TN 37219 US 37219


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-01

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