N/A SP-2359Recalls & reported problems
Biomet Microfixation, Inc · Class 1
Quick summary
This Biomet MicroFixation surgical elevator is a hand instrument used to lift bone during dental and other surgery. The 30 reports describe the tip breaking off or snapping during procedures, most often while removing or lifting tissue; reports also mention the tip twisting or bending once. None of the reports describe a death or an injury, and most say the patient was not affected. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00841036285302), received between Aug 5, 2020 and Mar 10, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (28 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
- Fracture28
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE ELEVATOR WAS FRACTURED DURING A PROCEDURE WITH NO PATIENT INJURY OR PROCEDURAL 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 21560237 ↗MalfunctionMar 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE ELEVATOR WAS FRACTURED DURING A PROCEDURE WITH NO PATIENT INJURY OR PROCEDURAL 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 21560226 ↗MalfunctionMar 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE ELEVATOR WAS FRACTURED DURING A PROCEDURE WITH NO PATIENT INJURY OR PROCEDURAL 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 21560224 ↗MalfunctionMay 28, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19406473 ↗MalfunctionMay 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED AT THE TIP DURING SURGERY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19405905 ↗MalfunctionMay 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED AT THE TIP DURING SURGERY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19405336 ↗MalfunctionMay 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED AT THE TIP DURING SURGERY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19405263 ↗MalfunctionMay 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED AT THE TIP DURING SURGERY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19404961 ↗MalfunctionNov 30, 2022Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING SURGERY. THERE WAS NO DELAY OR INJURY TO THE PATIENT. 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 15890815 ↗MalfunctionNov 30, 2022Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING SURGERY. THERE WAS NO DELAY OR INJURY TO THE PATIENT. 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 15890583 ↗MalfunctionNov 30, 2022Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING SURGERY. THERE WAS NO DELAY OR INJURY TO THE PATIENT. 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 15887556 ↗MalfunctionAug 22, 2022Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. 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 15264745 ↗MalfunctionAug 22, 2022Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. 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 15264728 ↗MalfunctionAug 22, 2022Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. 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 15264720 ↗MalfunctionAug 22, 2022Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. 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 15264705 ↗MalfunctionFeb 28, 2022Fracture; Fracture
IT WAS REPORTED THAT DEVICE BROKE DURING A PROCEDURE. HOWEVER, THERE WAS NO IMPACT TO THE PATIENT AND NO DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13618328 ↗MalfunctionFeb 28, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT DEVICE WAS DISCOVERED TWISTED AND BROKEN PRIOR TO SURGERY. THERE WAS NO DELAY OR IMPACT TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13618327 ↗MalfunctionFeb 28, 2022Fracture; Fracture
IT IS REPORTED THAT THE DEVICE BROKE DURING A PROCEDURE. HOWEVER, THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13618318 ↗MalfunctionFeb 1, 2022Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS BROKEN WITH NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13414700 ↗MalfunctionNov 7, 2021Fracture; Fracture
IT WAS REPORTED THAT THE TERMINAL PORTION OF THE ELEVATOR FRACTURED LUXATING INTERPROXIMAL AT #1 AND #2 TEETH. THE SURGICAL TECHNIQUE WAS PERFORMED PROPERLY DURING THE SURGERY. T WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12763405 ↗MalfunctionMay 4, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770732 ↗MalfunctionMay 4, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11770724 ↗MalfunctionMay 4, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11769111 ↗MalfunctionJan 5, 2021Fracture; Fracture
IT WAS REPORTED THE ELEVATOR TIP FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ELEVATOR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11121465 ↗MalfunctionNov 5, 2020Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT BROKE AT THE TIP DURING AN ELEVATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10791401 ↗
Other ELEVATOR, SURGICAL, DENTAL devices
- N/A 09-0257Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL57 reports
- N/A 09-0252Biomet Microfixation, Inc · ELEVATOR, SURGICAL, DENTAL49 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.