N/A 09-0386Recalls & reported problems
Biomet Microfixation, Inc · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841036029135), received between Jan 5, 2021 and Mar 29, 2021 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Crack” (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.
Most reported problems
Device problems
- Crack8
- Fracture5
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient6
- No Patient Involvement1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2021Crack; Crack
IT WAS REPORTED THAT TWO (2) ELEVATORS WERE FOUND CRACKED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11586370 ↗MalfunctionMar 29, 2021Crack; Crack
IT WAS REPORTED THAT TWO (2) ELEVATORS WERE FOUND CRACKED UPON RECEIPT OF THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11586368 ↗MalfunctionMar 4, 2021Crack; Crack
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11414293 ↗MalfunctionMar 4, 2021Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11414251 ↗MalfunctionMar 4, 2021Fracture; Fracture
IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. THE FRACTURE OCCURRED AT THE FLAT WIDER PORTION OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE INSTRUMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11414225 ↗MalfunctionMar 4, 2021Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11414219 ↗MalfunctionMar 4, 2021Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 11414209 ↗MalfunctionMar 4, 2021Crack; Fracture; Crack; Fracture
IT WAS REPORTED THE INSTRUMENT CRACKED DURING SURGERY. THE CRACK OCCURRED AT THE FLAT WIDER PORTION OF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE INSTRUMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11414185 ↗MalfunctionJan 5, 2021Crack; Material Separation; Crack; Material Separation
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11121477 ↗
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 09-0258Biomet 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.