BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BYTE DAY ALIGNERS

    MDR report key: 20587791 · Received November 1, 2024

    Report

    Report Number
    3014845255-2024-01992
    Event Type
    Injury
    Date Received
    November 1, 2024
    Report Date
    November 1, 2024
    Manufacturer
    STRAIGHT SMILE, LLC
    Product Code
    NXC
    UDI-DI
    00850017524163
    PMA / PMN Number
    K230199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A REPORTABLE MALFUNCTION, IT IS REPORTABLE PER 21CFR PART 803. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW INCLUDES THE DATE RANGE OF 05/17/2021 THROUGH 05/31/2024.

    Additional Manufacturer Narrative · 0

    NOTE: AN INCORRECT INITIAL 3500A SUBMISSION WAS INADVERTENTLY SUBMITTED FOR THIS MFR REPORT #. ALL PREVIOUSLY SUBMITTED INFORMATION WILL BE CORRECTED BY THE DATA PROVIDED IN THIS FOLLOW UP. SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21CFR PART 803. THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS AND HARMONIZATION MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THERE IS NO CHANGE TO DEVICE PERFORMANCE OR TO THE DEVICE RISK PROFILE. A CAPA (2023-487) HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING. THIS RETROSPECTIVE REVIEW INCLUDES THE DATE RANGE OF 05/17/2021 THROUGH 05/31/2024.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEIR BITE IS NOT AT END PROJECTION, BARELY MAKING CONTACT. CUSTOMER ALSO REPORTED WAS A CL1 BITE, PRIOR TO TX. CUST WAS SENT FOR REF. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED: CHIPPED TOOTH AND DISCOMFORT. THE PATIENT WAS ADVISED TO SEE A LOCAL DOCTOR OF DENTAL SURGERY AND WAS ASKED QUESTIONS REGARDING THE TOOTH. FIT TIPS WERE SHARED IN (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631556 BYTE DAY ALIGNERS ALIGNER, SEQUENTIAL NXC STRAIGHT SMILE, LLC HBYTE TRAY NA 00850017524163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown