MICRO-LINE GD450MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04038653444885), received between Jul 20, 2020 and Jul 30, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2021Leak/Splash; Leak/Splash

  NO UPDATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254197 ↗
• InjuryJul 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GD450M -MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM. ACCORDING TO THE COMPLAINT DESCRIPTION, WHEN THE DRILL WAS ACTIVATED, OIL OR WATER CAME OUT OF THE TIP AND DRIPPED INTO THE PATIENT'S MOUTH. THE DOCTOR USED SALINE SOLUTION TO RINSE THE PATIENT'S MOUTH RIGHT AWAY, AND ANOTHER TRAY WAS USED TO CONTINUE SURGERY. THE MALFUNCTION PROLONGED THE SURGERY AND REQUIRED MEDICAL INTERVENTION. THIS OCCURRED DURING A LE FORT PROCEDURE. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253745 ↗
• InjuryJul 20, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM. SPECIFICALLY, IT WAS REPORTED THAT DURING AN ORAL SURGERY, THE DRILL BECAME HOT AND BURNT THE PATIENT'S LIP. IT WAS THE PORTION THAT THE DRILL BIT FITS INTO.THE PATIENT'S BURN WAS TREATED WITH HYDROCORTISONE. THE PURPOSE OF THE PROCEDURE WAS TO CORRECT AN OVERBIT; THE JAW WAS CUT IN THREE PLACES AND MOVED OUT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THIS EVENT PROLONGED THE SURGERY FOR 10 MINUTES WHILE A NEW DRILL WAS BROUGHT INTO THE ROOM. THE CORD AND CONSOLE USED IN THE PROCEDURE WERE USED WITH A RECIPROCATING SAW WITHOUT AN ISSUE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00268 (400476403 + GA824). INVOLVED COMPONENTS: GA824 - ELAN 4 ELECTRO LOW SPEED MOTOR INTRA - 52278515.

  Patient problems: Burn, Thermal

  MAUDE report 10297735 ↗
• InjuryJul 20, 2020Overheating of Device; Temperature Problem; Temperature Problem

  ASSOCIATED MEDWATCH-REPORTS: 2916714-2020-00243 (B)(4), 2916714-2020-00242. INVOLVED COMPONENTS: GD450M - MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM - SERIAL NO. (B)(6). ADDITIONAL INFORMATION RECEIVED VIA INFORMATION FROM MW5095342: THE PATIENT WAS A SIX YEAR-OLD FEMALE. THE DEVICE WAS USED A PROCEDURE FOR MAXILLARY HYPOPLASIA, MANDIBULAR HYPOPLASIA, APERTOGNATHIA AND ASYMMETRY. THE PATIENT UNDERWENT A LEFORT 1 SEGMENTAL 3-PIECE OSTEOTOMY, BILATERAL SAGITTAL SPLIT OSTEOTOMY AND GENIOPLASTY. UPON USING THE LEDEMANN BUR, IT WAS NOTED THAT THE AESCULAP DRILL BECAME VERY HOT; DURING THE REMOVAL OF THE DRILL FROM THE PATIENT'S MOUTH, IT WAS NOTED THAT THE EXTENSION OF THE HAND PIECE WAS HOT AND HAD BURNED THE PATIENT'S LOWER RIGHT LIP. COLD SALINE WAS PLACED ON THE LIP IMMEDIATELY, AND SILVER SULFADIAZINE WAS PLACED, AND CONTINUED TO BE PLACED THROUGHOUT THE CASE. A NEW DRILL WAS REQUESTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, THE STERILIZATION PROCESS WAS REVIEWED AND NO FAILURES IN THE STERILIZATION OF THE DEVICE WERE NOTED.

  Patient problems: Burn, Thermal; Superficial (First Degree) Burn

  MAUDE report 10297665 ↗