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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRAIGHT SMILE , LLC BYTE DAY ALIGNER; ALIGNER, SEQUENTIAL

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STRAIGHT SMILE , LLC BYTE DAY ALIGNER; ALIGNER, SEQUENTIAL Back to Search Results
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Deformity/ Disfigurement (2360)
Event Type  Injury  
Event Description
While using a byte day aligner, patient is experiencing discomfort when biting.During exam it was found that the patient had an edge-to-edge/crossbite in the anterior and a posterior/right crossbite.The patient did not have this issue before the byte aligner treatment.Doctor advises patient to stop treatment, and suggested treatment of third molar surgery, use of orthodontic mechanics to correct the edge-to-edge bite.
 
Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.
 
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Brand Name
BYTE DAY ALIGNER
Type of Device
ALIGNER, SEQUENTIAL
Manufacturer (Section D)
STRAIGHT SMILE , LLC
1556 20th st. , suite a
santa monica CA 90404
Manufacturer (Section G)
STRAIGHT SMILE , LLC
1556 20th st. , suite a
santa monica CA 90404
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
york, PA 17401
7178494593
MDR Report Key18173514
MDR Text Key328565434
Report Number3014845255-2023-00110
Device Sequence Number1
Product Code NXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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