Medicon 75.23.39Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046826385583), received between Jan 9, 2019 and May 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 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, 2022Material Twisted/Bent; Material Twisted/Bent

  DURING A PROCEDURE INVOLVING PLACEMENT OF A TEMPORARY ANCHORAGE DEVICE (TAD)/SCREW IMPLANT BETWEEN THE LOWER RIGHT CUSPID AND 1 BICUSPID, THE SCREW WAS GRASPED WITH THE GRASPING BLADES OF THE SCREW INSERTION DEVICE THAT IS THE SUBJECT OF THIS MEDICAL DEVICE REPORT. THE GRASPING BLADES WERE TIGHTENED TO FIRMLY HOLD THE TAD AND THE TAD WAS PLACED. WHEN ATTEMPTING TO RELEASE THE TAD FROM THE INSERTION DEVICE, THE HEAD OF THE TAD BROKE OFF THE FLUTE PORTION. THE TAD HEAD REMAINED IN THE GRASP OF THE INSERTION DEVICE. TO RECOVER THE BROKEN FLUTE OF THE 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 AND A FOLLOW-UP APPOINTMENT.

  Patient problems: Failure of Implant

  MAUDE report 14516973 ↗
• MalfunctionJan 9, 2019Fracture; Use of Device Problem; Fracture; Use of Device Problem

  AFTER SUCCESSFUL IMPLANTATION OF AN ORTHODONTIC SCREW, THE USER ATTEMPTED TO REMOVE THE IMPLANTATION SLEEVE USING THE DEDICATED SCREWDRIVER. HOWEVER, THE SLEEVE WAS FIRMLY LODGED ON THE SCREW HEAD, THE SCREWDRIVER BLADE BROKE, AND ANOTHER INSTRUMENT WAS REQUIRED TO FORCIBLY REMOVE THE SLEEVE. THE ORTHODONTIC SCREW ALSO BROKE IN THE PROCESS (MANUFACTURER REPORT #2019-00003).

  Patient problems: No Information

  MAUDE report 8230639 ↗