N/A 09-0258Recalls & reported problems
Biomet Microfixation, Inc · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841036028190), received between Jun 26, 2019 and Jan 15, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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
- Fracture8
Patient problems
- No Known Impact Or Consequence To Patient6
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2025Fracture; Fracture
IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158909 ↗MalfunctionNov 4, 2020Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT BROKE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10784368 ↗MalfunctionNov 4, 2020Fracture; Fracture
IT WAS REPORTED THE TIP OF THE INSTRUMENT FRACTURED DURING A PROCEDURE RESULTING IN A 30 MINUTE DELAY DUE TO AN X-RAY BEING TAKEN TO SEARCH FOR FRACTURED PIECES. NO FRACTURED PIECES OF THE INSTRUMENT WERE FOUND IN THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10784364 ↗MalfunctionMar 17, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9841651 ↗MalfunctionFeb 12, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9702437 ↗MalfunctionDec 6, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9428460 ↗MalfunctionNov 15, 2019Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9330484 ↗MalfunctionJun 26, 2019Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT FRACTURED AT THE TIP DURING A PROCEDURE. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY TO THE CASE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8735605 ↗
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 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 09-0259Biomet 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.