2.4MM SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 68
- Recalls
- 0
We found 7 models of 2.4MM SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 70 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2019 and Nov 8, 2021 — classified as 68 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (11 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
Most reported 2.4MM SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem42
- Patient-Device Incompatibility11
- Device Dislodged or Dislocated10
- Migration or Expulsion of Device5
- Material Integrity Problem3
- Noise, Audible3
- Fracture2
- Malposition of Device2
Patient problems
- Pain37
- Inadequate Pain Relief12
- Nerve Damage11
- No Information11
- Unspecified Infection9
- Swelling8
- Difficulty Chewing7
- No Code Available7
2.4MM SYSTEM models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 2.4MM SYSTEM 91-2710Plate, Bone37 reports
- 2.4MM SYSTEM 91-2708Plate, Bone21 reports
- 2.4MM SYSTEM 91-2712Plate, Bone8 reports
- 2.4MM SYSTEM 81-2710Plate, Bone1 report
- 2.4MM SYSTEM 91-2716Plate, Bone1 report
- 2.4MM SYSTEM 91-2714Plate, Bone1 report
- 2.4MM SYSTEM 91-2718Plate, Bone1 report
Recent 2.4MM SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2021Malposition of Device; Malposition of Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12770286 ↗MalfunctionNov 8, 2021Malposition of Device; Malposition of Device
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12770285 ↗InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection
MAUDE report 11278189 ↗InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection
MAUDE report 11278179 ↗InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AND DIFFICULTY CHEWING ELEVEN (11) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. THE PATIENT INDICATES THAT THE PAIN IS BETTER THAN BEFORE THE SURGERY BUT IS STILL BEING EXPERIENCED. THE PATIENT REPORTS THAT THEIR JAW HAS SHIFTED SO THAT THEIR TEETH DO NOT TOUCH, AND AS A RESULT THE PATIENT CANNOT CHEW OR TEAR MEAT. THE PATIENT HAS BROKEN SEVERAL TEETH DUE TO BRUXISM AND THEIR DENTIST BELIEVES THE BREAKAGES ARE DUE TO TRAUMA FROM THE INITIAL SURGERY. THE PATIENT RECEIVES BOTOX SHOTS FOR BURNING OR FIRING NERVES THAT CAUSE PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Difficulty Chewing; Loss of Range of Motion; Pain
MAUDE report 10791428 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Hearing Loss; Pain; Rupture
MAUDE report 10777365 ↗InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Hearing Loss; Pain; Rupture
MAUDE report 10777357 ↗InjuryOct 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Pain Relief; Nerve Damage; Pain
MAUDE report 10747191 ↗InjuryOct 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inadequate Pain Relief; Nerve Damage; Pain
MAUDE report 10747147 ↗InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THREE (3) YEARS AGO. IMMEDIATELY FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED BELL¿S PALSY ON THE RIGHT SIDE AND WAS INFORMED BY THE SURGEON THAT IT WAS A POSSIBLE REACTION TO THE SURGERY. THE PATIENT HAS USED A BITE SPLINT FOR THREE (3) YEARS TO ALIGN THE BITE. THE PATIENT HAD A ROOT CANAL A COUPLE MONTHS AGO AND THE ENDODONTIST TOOK CONE BEAM IMAGING. BASED ON THE IMAGING, THE ENDODONTIST BELIEVES THE DEVICE IS RUBBING THE BONE AND THAT THE SPLINT INCREASES THE PAIN. THE PATIENT HAS AN UNSPECIFIED ONE (1) INCH DEFORMITY IN THE JAW. THE PATIENT UNDERWENT A DRY NEEDLING TREATMENT ONE (1) YEAR AGO THAT DID NOT PROVIDE ADEQUATE PAIN RELIEF. THE PATIENT WISHES TO GET A REFERRAL TO A NEUROLOGIST TO SEE IF A SCREW IS POTENTIALLY HITTING A NERVE. THE PATIENT IS NOT INTERESTED IN A REVISION SURGERY UNLESS IT WOULD BRING PAIN RELIEF. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Facial Nerve Paralysis; Inadequate Pain Relief; Nerve Damage; Pain
MAUDE report 10689175 ↗InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THREE (3) YEARS AGO. IMMEDIATELY FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED BELL¿S PALSY ON THE RIGHT SIDE AND WAS INFORMED BY THE SURGEON THAT IT WAS A POSSIBLE REACTION TO THE SURGERY. THE PATIENT HAS USED A BITE SPLINT FOR THREE (3) YEARS TO ALIGN THE BITE. THE PATIENT HAD A ROOT CANAL A COUPLE MONTHS AGO AND THE ENDODONTIST TOOK CONE BEAM IMAGING. BASED ON THE IMAGING, THE ENDODONTIST BELIEVES THE DEVICE IS RUBBING THE BONE AND THAT THE SPLINT INCREASES THE PAIN. THE PATIENT HAS AN UNSPECIFIED ONE (1) INCH DEFORMITY IN THE JAW. THE PATIENT UNDERWENT A DRY NEEDLING TREATMENT ONE (1) YEAR AGO THAT DID NOT PROVIDE ADEQUATE PAIN RELIEF. THE PATIENT WISHES TO GET A REFERRAL TO A NEUROLOGIST TO SEE IF A SCREW IS POTENTIALLY HITTING A NERVE. THE PATIENT IS NOT INTERESTED IN A REVISION SURGERY UNLESS IT WOULD BRING PAIN RELIEF. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Facial Nerve Paralysis; Inadequate Pain Relief; Nerve Damage; Pain
MAUDE report 10689172 ↗InjuryOct 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Erythema; Itching Sensation; Reaction; Unspecified Infection; Urticaria
MAUDE report 10637425 ↗InjuryOct 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TO REMOVE TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE DUE TO ALLERGIC REACTION EIGHT (8) MONTHS FOLLOWING IMPLANTATION. THE PATIENT REPORTS THERE WAS AN ALLERGY TEST PRIOR TO IMPLANTATION THAT CONFIRMED A NICKEL ALLERGY BUT THERE WAS NO INDICATION OF A TITANIUM ALLERGY AT THAT TIME. ONE (1) MONTH FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED REDNESS, ITCHING AND HIVES ON THE JAW, EAR, THROAT AND NECK. A TITANIUM ALLERGY WAS CONFIRMED APPROXIMATELY TWO (2) MONTHS FOLLOWING IMPLANTATION. THE PATIENT WAS PRESCRIBED NINE (9) MEDICATIONS TO TREAT A REPORTED FACIAL INFECTION. THE PATIENT IS CURRENTLY ON IV MEDICATION FOR EIGHT (8) WEEKS FOLLOWING AN EYE REACTION THAT OCCURRED FOLLOWING THE REMOVAL OF THE IMPLANT. THE PATIENT IS DISCUSSING IMPLANT REPLACEMENT OPTIONS WITH THEIR SURGEON. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: Erythema; Itching Sensation; Reaction; Unspecified Infection; Urticaria
MAUDE report 10637402 ↗InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 10590388 ↗InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 10590382 ↗
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
- 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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