2.0MM SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 11 models of 2.0MM SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2019 and Sep 8, 2025 — classified as 11 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Fracture” (44 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported 2.0MM SYSTEM problems
Device problems
- Fracture44
- Flaked4
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Dull, Blunt1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient5
- Injury4
- No Consequences Or Impact To Patient4
- Foreign Body In Patient2
- Unspecified Infection2
- Insufficient Information1
2.0MM SYSTEM models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 2.0MM SYSTEM 01-9198Drills, Burrs, Trephines & Accessories (Simple, Powered)13 reports
- 2.0MM SYSTEM 01-9181Drills, Burrs, Trephines & Accessories (Simple, Powered)11 reports
- 2.0MM SYSTEM 01-9196Drills, Burrs, Trephines & Accessories (Simple, Powered)11 reports
- 2.0MM SYSTEM 01-9193Drills, Burrs, Trephines & Accessories (Simple, Powered)4 reports
- 2.0MM SYSTEM 01-9195Drills, Burrs, Trephines & Accessories (Simple, Powered)3 reports
- 2.0MM SYSTEM 01-9203DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)3 reports
- 2.0MM SYSTEM 01-7696Screwdriver1 report
- 2.0MM SYSTEM 01-9180Drills, Burrs, Trephines & Accessories (Simple, Powered)1 report
- "2.0MM" SYSTEM 01-9232PLATE, BONE1 report
- "2.0MM SYSTEM" 91-2005Plate, cranioplasty, preformed, alterable1 report
- "2.0MM" SYSTEM 95-6205COVER, BURR HOLE1 report
Recent 2.0MM SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993469 ↗MalfunctionApr 1, 2025Fracture; Fracture
IT WAS REPORTED THAT A DRILL FRACTURED NEAR THE ROOT DURING AN INITIAL FIXATION PROCEDURE. THE CORRECT SURGICAL TECHNIQUE WAS USED AND THE SURGEON NOTED THAT THE BREAKAGE MAY HAVE OCCURRED DUE TO THE APPLICATION OF OBLIQUE FORCE ON A LONG DRILL WITHOUT A GUIDE. THE FRACTURED DRILL TIP WAS SUCCESSFULLY REMOVED, AND THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21742672 ↗MalfunctionMar 13, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593115 ↗MalfunctionFeb 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21457568 ↗InjuryAug 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT WITH A JAW DEFORMITY UNDERWENT A COMBINED IVRO AND SSRO PROCEDURE. LATER, AN X-RAY CONFIRMED THAT A SCREW ON THE IVRO SIDE LOOSEND FROM THE PLATE, AND INFECTION WAS SUSPECTED. INFECTION WAS CONFIRMED AND TREATMENT WAS STARTED. SUBSEQUENTLY, PATIENT WAS REVISED. THE SURGEON HAS DETERMINED THAT THE DISLODGED SCREW MAY HAVE HAD SOME EFFECT ON THE DEVELOPMENT OF THE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20076324 ↗InjuryJul 2, 2024Fracture; Fracture
NO FURTHER EVET INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19655816 ↗MalfunctionMar 28, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DRILL TIP FRACTURED WHILE IN USE DURING A PROCEDURE. THE DRILL TIP REMAINED IN THE PATIENT SO THE SURGEON PROCEEDED TO REMOVE THE FRAGMENT. THE SURGEON INJURED HIS FINGER WHILE REMOVING THE DRILL FRAGMENT. THERE WAS NO FURTHER INFORMATION PROVIDED FOR THE SURGEON'S INJURY. NO FRAGMENTS WERE RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19001294 ↗MalfunctionFeb 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DRILLS FRACTURED WHILE DRILLING A HOLE FOR SCREW INSERTIONS DURING AN OSTEOTOMY PROCEDURE FOR JAW DEFORMITY. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18627508 ↗MalfunctionFeb 1, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DRILLS FRACTURED WHILE DRILLING A HOLE FOR SCREW INSERTIONS DURING AN OSTEOTOMY PROCEDURE FOR JAW DEFORMITY. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18627499 ↗MalfunctionDec 18, 2023Fracture; Fracture
IT IS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE, THE DRILL TIP FRACTURED WHILE DRILLING TO INSERT A SCREW. NO FRAGMENTS WERE RETAINED BY THE PATIENT, AND THERE WAS NO HARM OR INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18345479 ↗MalfunctionNov 7, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DRILL FRACTURED DURING AN INTERMAXILLARY FIXATION PROCEDURE. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE.THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18084769 ↗MalfunctionNov 7, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18084745 ↗MalfunctionApr 20, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16775176 ↗MalfunctionApr 20, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE DEVICE FRACTURED. SUBSEQUENTLY, THE SURGEON USED A SPARE DRILL TO COMPLETE THE SURGERY. 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 16775175 ↗MalfunctionMar 28, 2023Fracture; Fracture
THE TWO-DRILL TIP WERE BROKEN WHEN USED ON THE MANDIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16627385 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- 2.0 LACTOSORB SYSTEM16 models · 110 reports
- TRAUMAONE SYSTEM39 models · 80 reports
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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