N/A 09-0257Recalls & reported problems
Biomet Microfixation, Inc · Class 1
Quick summary
This Biomet MicroFixation surgical elevator is a hand instrument used to lift tissue during dental surgery. Most of the 57 reports describe the instrument tip fracturing or breaking off during a procedure, with 56 malfunctions, one injury and no deaths. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00841036028176), received between Feb 26, 2019 and Jan 29, 2026 — classified as 1 injury, 56 malfunctions.
The most frequently reported specific device problem is “Fracture” (55 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.
Reports received per month
Most reported problems
Device problems
- Fracture55
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Known Impact Or Consequence To Patient13
- No Consequences Or Impact To Patient6
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206736 ↗MalfunctionDec 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785370 ↗MalfunctionDec 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785365 ↗MalfunctionDec 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785364 ↗MalfunctionDec 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23785360 ↗MalfunctionAug 26, 2024Fracture; Fracture
IT IS REPORTED THAT THE TIP OF THE INSTRUMENT FRACTURED DURING A PROCEDURE. THE FRACTURED TIP WAS RECOVERED, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064080 ↗MalfunctionMay 15, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16929159 ↗MalfunctionApr 24, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16799511 ↗MalfunctionApr 24, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16799509 ↗MalfunctionApr 5, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16682083 ↗MalfunctionJan 5, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16103350 ↗MalfunctionJan 5, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16102983 ↗MalfunctionSep 26, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15486632 ↗MalfunctionSep 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15474222 ↗MalfunctionSep 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15473813 ↗MalfunctionSep 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15473755 ↗MalfunctionSep 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15473391 ↗MalfunctionSep 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15473386 ↗MalfunctionSep 23, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15473198 ↗InjurySep 13, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR FRACTURED DURING A TOOTH EXTRACTION PROCEDURE. THERE WAS NO HARM OR INJURY, AND NO DELAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15411631 ↗MalfunctionJun 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR HAD BROKEN TIPS DURING A PROCEDURE. ALL BROKEN PIECES WERE EITHER RECOVERED, OR SUCTIONED AND THROWN AWAY. THERE WAS NO PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596657 ↗MalfunctionJun 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR HAD BROKEN TIPS DURING A PROCEDURE. ALL BROKEN PIECES WERE EITHER RECOVERED, OR SUCTIONED AND THROWN AWAY. THERE WAS NO PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596634 ↗MalfunctionJun 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR HAD BROKEN TIPS DURING A PROCEDURE. ALL BROKEN PIECES WERE EITHER RECOVERED, OR SUCTIONED AND THROWN AWAY. THERE WAS NO PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596629 ↗MalfunctionJun 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR HAD BROKEN TIPS DURING A PROCEDURE. ALL BROKEN PIECES WERE EITHER RECOVERED, OR SUCTIONED AND THROWN AWAY. THERE WAS NO PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596570 ↗MalfunctionJun 3, 2022Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR HAD BROKEN TIPS DURING A PROCEDURE. ALL BROKEN PIECES WERE EITHER RECOVERED, OR SUCTIONED AND THROWN AWAY. THERE WAS NO PATIENT INJURY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596542 ↗
Other ELEVATOR, SURGICAL, DENTAL devices
- N/A 09-0252Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL49 reports
- N/A SP-2359Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL28 reports
- N/A 09-0313Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL17 reports
- N/A 09-0262Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL15 reports
- N/A 09-0386Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL9 reports
- N/A 09-0258Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL8 reports
- N/A 09-0259Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL8 reports
- N/A 09-0394Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.