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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Deformity/ Disfigurement (2360); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.

Event Description

While using a byte day aligners, patient was examined by their dentist; intraoral exam revealed generalized 2mm to 9mm probing depths.There is extensive generalized subgingival calculus detected.Advanced mobility is noted at #24 and #25.Radiographic exam revealed generalized moderate-severe horizontal bone loss, as well as complete loss of bony support at #24 and #25.There is also extensive bone loss at #23 and #26 mesial, as well as evidence of vertical bone loss present at several sites.Subgingival calculus is also detected.Dentist recommends the following: 4 quads of scaling and root planing for phase 1 periodontal therapy.After treatment is complete a review will be made as for phase 2, if surgical therapy is required - extractions.A cbct scan was done which revealed severely limited dimension of bone for implant therapy at #24 and #25.Widened pdls are also noted at several teeth which is likely due to recent orthodontic movement.These sites are not recommended for implant therapy due to the lack of adequate vertical bone.Alternative replacement options were reviewed.Dentist recommended extractions of #24 and #25 with bone grafting in order to help attempt to preserve the bone on the mesial aspects of #23 and #26.Patient has chosen to move forward with the recommended treatment.

• 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: dan eagar ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18793537
• MDR Text Key: 336397795
• Report Number: 3014845255-2024-00077
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• 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 Number: 1
• Patient Outcome(s): Required Intervention