Medicon 68.99.34ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046826385576), received between Jun 10, 2020 and May 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Fracture; Fracture

  IN ACCORDANCE WITH THE HEALTHCARE PROVIDER'S REPORT, THE PROCEDURE INVOLVED PLACEMENT OF THREE TEMPORARY ANCHORAGE DEVICES (TADS). THE PATIENT WAS GIVEN PRE-OP RX AMOXICILLIN 250 MG X4 & RINSED WITH PERIOGUARD. THE PATIENT WAS PLACED ON 50% NO2 WITH TOPICAL ANESTHESIA BILATERAL SUPERIOR POSTERIOR TO PALATE AND BILATERAL BUCCAL LOWER LOCAL LIDOCAINE 2% EPI. THE LOWER RIGHT BUCCAL TAD WAS TO BE PLACED BETWEEN THE RIGHT CUSPID AND 1 BICUSPID. THE PLACEMENT LOCATION WAS TAPPED, AND THE TAD WAS PLACED IN THE DRIVER. THE TAD WAS PLACED. UPON REMOVAL OF THE DRIVER ATTACHMENT TO THE TAD BIT, THE HEAD OF THE TAD BROKE OFF THE FLUTE PORTION. TO RECOVER THE BROKEN TAD (FLUTE OF TAD), A FLAP WAS RAISED FROM THE RIDGE OF THE MISSING 2" BICUSPID TO THE DISTAL OF THE CUSPID AND A VERTICAL RELEASING INCISION WAS MADE OVER THE BROKEN TAD. THE FLUTE PART OF THE TAD WAS LOCATED. BONE WAS REMOVED CIRCUMFERENTIALLY AROUND THE TAD TO ALLOW THE PLACEMENT OF A HEMOSTAT AROUND THE EXPOSED PORTION OF THE TAD. THE BROKEN TAD WAS BACKED OUT USING THE HEMOSTAT. THEN THE FLAP WAS CLOSED BY SUTURING THE VERTICAL AND GINGIVAL INCISIONS TOGETHER. THE PATIENT WAS GIVEN POST OP INSTRUCTIONS, INSTRUCTIONS FOR PAIN AN

  Patient problems: Failure of Implant

  MAUDE report 14516221 ↗
• MalfunctionJun 10, 2020Fracture; Fracture

  BEFORE SETTING THE SCREW THE DOCTOR DRILLED THE BONE TO PREPARE FOR INSERTION. THE SCREW BROKE AT A DEPTH OF 4.6 MM DURING THE SCREWING PROCESS. ACCORDING TO THE DOCTOR, THE SCREW TIP REMAINS IN THE PATIENT'S JAW AND SURGERY WILL BE NECESSARY TO REMOVE THE DEVICE FRAGMENT. (DEVICE 1 OF 2).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10136823 ↗