MAUDE Adverse Event Report: ALLESEE ORTHODONTIC APPLIANCES SIMPLI5; ALIGNER

Lot Number	4234248
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient presented with potential lock jaw during treatment with simpli5 aligners.Simpli5 treatment was discontinued and a referral to a tmj specialist was given to the patient.Telephone discussion with the specialist would indicate diagnosis of tmd.The patient was wearing the aligner when symptoms developed, however, the specialist indicated there is only a slight change the aligners may have contributed to the diagnosis, provided the patient wore both appliances simultaneously.The orthodontist stated the patient's lower jaw may have been protrusive prior to aligner treatment and may have also been a contributing factor to the diagnosis.
Event or Problem Description
Doctor alleged patient wore first tray and developed lock jaw.Patient is seeking medical treatment.

• Brand Name: SIMPLI5
• Common Device Name: ALIGNER
• Manufacturer (Section D): ALLESEE ORTHODONTIC APPLIANCES; 13931 spring street; sturtevant WI 53177
• MDR Report Key: 6847016
• Report Number: 2184045-2017-00001
• Device Sequence Number: 1419865
• Product Code: NXC
• UDI-Device Identifier: 00889989061918
• UDI-Public: 00889989061918
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K040874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Lot Number: 4234248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR