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Carriere® SLX 3D™ 777-LR4-HK-10Recalls & reported problems

Ortho Organizers, Inc. · Carriere® SLX 3D™ .022 LR4 HK -12T 2A 0O Self-Ligating Brackets · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190707048273), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Sharp Edges” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Sharp Edges1

Patient problems

  • Abrasion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2023Sharp Edges; Sharp Edges

    IT WAS REPORTED IN THE CUSTOMER COMPLAINT FORM THAT BRACKET LR4 HAD SHARP EDGES CAUSING CHEEK IRRITATION, CUTTING THE CHEEK ON THE LOWER RIGHT OF THE PATIENT AND CAUSING LARGE SORES THAT DID NOT HEAL. THE SYMPTOMS BEGAN THE DAY AFTER THE BRACKET WAS PLACED. THE BRACKET NEEDED TO BE REMOVED AND REPLACED WITH A DIFFERENT BRAND. THE 38-YEAR OLD FEMALE PATIENT WAS PRESCRIBED KENALOG IN ORABASE, A TOPICAL STEROID. SHE WAS ALSO ADVISED TO TAKE OTC PAIN MEDICATION SUCH AS IBUPROFEN AND TYLENOL.

    Patient problems: Abrasion

    MAUDE report 17847057 ↗

Other BRACKET, METAL, ORTHODONTIC devices

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Sources and updates

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