Henry Schein Maxima 5700108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00304040058336), received between May 21, 2024 and Oct 19, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• MalfunctionOct 19, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, WHILE DOCTOR WAS WORKING ON CHILD PATIENT, BUR SLIPPED OUT OF CHUCK FROM THE HANDPIECE, MAXIMA ELITE MINI L (B)(4), AND CUT CHILD'S CHEEK.

  Patient problems: Laceration(s)

  MAUDE report 23333981 ↗
• InjuryJul 18, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  WHILE DOCTOR WAS WORKIN ON CHILD PATIENT, BUR SLIPPED OUT OF CHUCK AND CUT CHILD'S CHEEK.

  Patient problems: Laceration(s)

  MAUDE report 22541661 ↗
• MalfunctionMay 24, 2024Burst Container or Vessel; Burst Container or Vessel

  AT FIRST, THE DOCTOR WAS HAVING "PRESSURE AND NOT CUTTING ISSUES" WITH THE PRODUCT. THE DOCTOR SENT THE PRODUCT OVER TO PRO REPAIR. THEN, AFTER RECEIVING THE PRODUCT, THE DOCTOR USED THE HANDPIECE ON A 6 YEAR OLD MALE PATIENT AND IT EXPLODED IN THE PATIENTS MOUTH. THE PATIENT WAS SEDATED AND THEY WERE ABLE TO RETRIEVE ALL THE PARTS. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391236 ↗
• InjuryMay 21, 2024Burst Container or Vessel; Burst Container or Vessel

  AT FIRST, THE DOCTOR WAS HAVING "PRESSURE AND NOT CUTTING ISSUES" WITH THE PRODUCT. THE DOCTOR SENT THE PRODUCT OVER TO PRO REPAIR. THEN, AFTER RECEIVING THE PRODUCT, THE DOCTOR USED THE HANDPIECE ON A 6 YEAR OLD MALE PATIENT AND IT EXPLODED IN THE PATIENTS MOUTH. THE PATIENT WAS SEDATED AND THEY WERE ABLE TO RETRIEVE ALL THE PARTS. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359659 ↗