N/A 09-0252Recalls & reported problems
Biomet Microfixation, Inc · Class 1
Quick summary
This Biomet MicroFixation elevator is a surgical instrument used to lift bone or tissue during dental and orthopedic procedures. The reports mostly describe the elevator tip snapping or breaking during use, sometimes leaving a fragment in the patient that was retrieved. There are 49 reports, no deaths and 1 injury. No recalls name 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
- 49
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00841036028152), received between Apr 26, 2019 and Aug 12, 2025 — classified as 1 injury, 48 malfunctions.
The most frequently reported specific device problem is “Fracture” (47 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
- Fracture47
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient10
- No Consequences Or Impact To Patient3
- Foreign Body In Patient1
- No Information1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2025Fracture; Fracture
IT WAS REPORTED THAT THE ELEVATOR WAS FRACTURED DURING A PROCEDURE. NO PATIENT HARM OR DELAY WAS REPORTED. 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 22782469 ↗MalfunctionMar 27, 2025Fracture; Fracture
IT IS REPORTED THAT THE TIP OF INSTRUMENT WAS FRACTURED. THERE WAS NO PATIENT HARM AND THIS DID NOT OCCUR DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713054 ↗MalfunctionMar 27, 2025Fracture; Fracture
IT IS REPORTED THAT THE TIP OF INSTRUMENT WAS FRACTURED. THERE WAS NO PATIENT HARM AND THIS DID NOT OCCUR DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21713044 ↗MalfunctionDec 10, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20892962 ↗MalfunctionNov 4, 2024Fracture; Fracture
IT WAS REPORTED THE TIP OF THE ELEVATOR WAS FRACTURED DURING A PROCEDURE. NO PATIENT HARM AND FRAGMENT WAS RETRIEVED. 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 20599026 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19987882 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986173 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986105 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986093 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986077 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986039 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT IS REPORTED THAT THE INSTRUMENT TIPS FRACTURED IN THE SAME LOCATION. THE REPORTER INDICATED THAT THERE WAS NO INJURY OR DELAY DUE TO THE FRACTURED INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19986018 ↗MalfunctionAug 14, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19985951 ↗MalfunctionAug 14, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19985797 ↗MalfunctionAug 29, 2023Fracture; Fracture
IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WERE NO INJURIES OR DELAYS WITH ALL FRACTURED PIECES ACCOUNTED FOR AT THE PROCEDURE. 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 17641486 ↗MalfunctionAug 29, 2023Fracture; Fracture
IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WERE NO INJURIES OR DELAYS WITH ALL FRACTURED PIECES ACCOUNTED FOR AT THE PROCEDURE. 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 17641477 ↗MalfunctionAug 29, 2023Fracture; Fracture
IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WERE NO INJURIES OR DELAYS WITH ALL FRACTURED PIECES ACCOUNTED FOR AND RETURNED. 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 17641475 ↗MalfunctionAug 25, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17624852 ↗MalfunctionJun 14, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17125715 ↗MalfunctionApr 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773048 ↗MalfunctionApr 19, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE DEVICE FRACTURED. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16773016 ↗MalfunctionApr 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16772818 ↗MalfunctionApr 19, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE DEVICE FRACTURED. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THIS EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16772815 ↗MalfunctionApr 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16772805 ↗MalfunctionApr 12, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16728904 ↗
Other ELEVATOR, SURGICAL, DENTAL devices
- N/A 09-0257Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL57 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.