TRAUMAONE SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 39 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 80
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls
- 0
We found 39 models of TRAUMAONE SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2019 and Apr 29, 2026 — classified as 36 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Fracture” (62 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 TRAUMAONE SYSTEM problems
Device problems
- Fracture62
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information4
- Patient-Device Incompatibility3
- Dull, Blunt2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Material Twisted/Bent2
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Known Impact Or Consequence To Patient20
- Foreign Body In Patient11
- Failure of Implant6
- No Information6
- Unspecified Infection6
- Pain3
- Difficulty Chewing2
TRAUMAONE SYSTEM models
39 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRAUMAONE SYSTEM 46-1007DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)12 reports
- TraumaOne SYSTEM 41-2010PLATE, BONE9 reports
- TRAUMAONE SYSTEM 46-1006DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)6 reports
- TRAUMAONE SYSTEM 46-1004DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)3 reports
- TRAUMAONE SYSTEM 91-5607SCREW, FIXATION, INTRAOSSEOUS3 reports
- TRAUMAONE SYSTEM 44-1023PLATE, BONE3 reports
- TraumaOne SYSTEM 41-2012PLATE, BONE3 reports
- TraumaOne SYSTEM 46-1006DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)3 reports
- TRAUMAONE SYSTEM 41-2010PLATE, BONE2 reports
- TRAUMAONE SYSTEM 91-5611SCREW, FIXATION, INTRAOSSEOUS2 reports
- TraumaOne SYSTEM SP-2379SCREWDRIVER2 reports
- TRAUMAONE SYSTEM 91-5609SCREW, FIXATION, INTRAOSSEOUS2 reports
- TRAUMAONE SYSTEM SP-3236SCREW, FIXATION, INTRAOSSEOUS2 reports
- TraumaOne SYSTEM 41-2412PLATE, BONE2 reports
- TraumaOne SYSTEM 45-2008PLATE, BONE2 reports
- TRAUMAONE SYSTEM 42-1004PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2005PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2006PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2008PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2414PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2410PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2408PLATE, BONE1 report
- TRAUMAONE SYSTEM 41-2305PLATE, BONE1 report
- TRAUMAONE SYSTEM 44-1012Screw, fixation, bone1 report
- TraumaOne SYSTEM 46-0007HANDLE, INSTRUMENT, DENTAL1 report
- TRAUMAONE SYSTEM SP-2376PLATE, BONE1 report
- TRAUMAONE SYSTEM 72-2030DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- TRAUMAONE SYSTEM SP-3210-LPLATE, BONE1 report
- TRAUMAONE SYSTEM SP-3210-RPLATE, BONE1 report
- TraumaOne SYSTEM 46-0005INSTRUMENT, MANUAL, SURGICAL, GENERAL USE1 report
- TraumaOne SYSTEM 41-2014PLATE, BONE1 report
- TraumaOne SYSTEM 41-2016PLATE, BONE1 report
- TraumaOne SYSTEM 41-2112PLATE, BONE1 report
- TraumaOne SYSTEM 41-2312PLATE, BONE1 report
- TraumaOne SYSTEM 45-2010PLATE, BONE1 report
- TraumaOne SYSTEM 43-1016PLATE, BONE1 report
- TraumaOne SYSTEM 46-1007DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- TraumaOne SYSTEM SP-2292PLATE, BONE1 report
- TraumaOne SYSTEM SP-2978PLATE, BONE1 report
Recent TRAUMAONE SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Fracture
IT WAS REPORTED THAT DURING FIXATION OF A MESH TO A FOUR-HOLE PLATE USING 2.0 X 10 MM SCREWS, ONE SCREW FRACTURED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035775 ↗MalfunctionJan 2, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943234 ↗MalfunctionJan 2, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943222 ↗MalfunctionDec 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE IMPLANTATION OF A STRAIGHT PLATE, TWO SCREWS FRACTURED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THE TIME OF THIS REPORT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769569 ↗MalfunctionDec 10, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769544 ↗InjuryDec 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE IMPLANTATION OF A STRAIGHT PLATE, TWO SCREWS FRACTURED. ONE OF THE FRACTURED SCREWS WAS NOT ABLE TO BE REMOVED AND WAS RETAINED. THE SURGEON NOTED THAT THE FRACTURED SCREW WAS SERVING ITS INTENDED PURPOSE, SO IT WAS LEFT WITHIN THE PATIENT. IT IS UNKNOWN WHICH SCREW WAS RETAINED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23769542 ↗InjuryDec 10, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING THE IMPLANTATION OF A STRAIGHT PLATE, TWO SCREWS FRACTURED. ONE OF THE FRACTURED SCREWS WAS NOT ABLE TO BE REMOVED AND WAS RETAINED. THE SURGEON NOTED THAT THE FRACTURED SCREW WAS SERVING ITS INTENDED PURPOSE, SO IT WAS LEFT WITHIN THE PATIENT. IT IS UNKNOWN WHICH SCREW WAS RETAINED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23769510 ↗MalfunctionMay 27, 2025Fracture; Fracture
IT WAS REPORTED THAT STAFF IDENTIFIED A FRACTURED DRILL BEFORE SURGERY DURING PREPARATION FOR AN INITIAL PROCEDURE. THE DRILL HAD BEEN USED MULTIPLE TIMES, AND THE FRACTURE WAS PRESENT BEFORE STERILIZATION, WHILE STILL AT THE HOSPITAL. THE DEVICE WAS REPORTED TO HAVE BEEN USED AS A LOANER AND WAS RETURNED TO THE DISTRIBUTOR FOLLOWING USE. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088121 ↗InjuryFeb 5, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21316044 ↗MalfunctionNov 15, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696011 ↗MalfunctionOct 16, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE FOR FIXATION OF THE PLATE IN THE MANDIBLE, THE SCREW FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461708 ↗MalfunctionOct 16, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREW FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461703 ↗MalfunctionOct 16, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE INVOLVING THE PLACEMENT OF THE BONE FLAP, THE SCREW FRACTURED. THE PROPER SURGICAL TECHNIQUE WAS USED. THE FRACTURED SCREW PARTS WERE REMOVED FROM THE PATIENT, AND THE PROCEDURES WERE COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20461556 ↗MalfunctionSep 19, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20256042 ↗MalfunctionSep 19, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT WHEN THE DRILL WAS HANDED TO THE SURGEON, IT WAS DISCOVERED THAT IT WAS BENT. THE SURGEON ATTEMPTED TO STRAIGHTEN THE DRILL, HOWEVER IT FRACTURED. 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 20256011 ↗
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
- 2.4MM SYSTEM7 models · 70 reports
- RIBFIX BLU SYSTEM19 models · 56 reports
- PECTUS SYSTEM35 models · 55 reports
- STERNALOCK 360 SYSTEM3 models · 51 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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