2.0 LACTOSORB SYSTEMRecalls & reported problems across all models
Biomet Microfixation, Inc · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls
- 0
We found 16 models of 2.0 LACTOSORB SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between May 24, 2019 and Jun 22, 2026 — classified as 48 injuries, 62 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (21 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 2.0 LACTOSORB SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem36
- Device-Device Incompatibility21
- Fracture18
- Detachment of Device or Device Component16
- Difficult to Insert4
- Patient-Device Incompatibility4
- Positioning Problem4
- Output Problem3
Patient problems
- Swelling/ Edema29
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient27
- Bacterial Infection18
- Purulent Discharge18
- No Known Impact Or Consequence To Patient7
- Unspecified Infection7
- Inflammation5
2.0 LACTOSORB SYSTEM models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 2.0 LACTOSORB SYSTEM 915-2301PLATE, FIXATION, BONE32 reports
- 2.0 LACTOSORB SYSTEM 915-2201Screw, fixation, bone28 reports
- 2.0 LACTOSORB SYSTEM 915-2200Screw, fixation, bone19 reports
- 2.0 LACTOSORB SYSTEM 915-2111PLATE, FIXATION, BONE5 reports
- 2.0 LACTOSORB SYSTEM 915-2101Screw, fixation, bone4 reports
- 2.0 LACTOSORB SYSTEM 915-2102Screw, fixation, bone4 reports
- 2.0 LACTOSORB SYSTEM 915-2151Screw, fixation, bone4 reports
- 2.0 LactoSorb System 915-2301-EAPlate, fixation, bone3 reports
- 2.0 LACTOSORB SYSTEM 915-2103Screw, fixation, bone2 reports
- 2.0 LACTOSORB SYSTEM 915-2110PLATE, FIXATION, BONE2 reports
- 2.0 LACTOSORB SYSTEM 915-2208Screw, fixation, bone2 reports
- 2.0 LACTOSORB SYSTEM 915-2109Screw, fixation, bone1 report
- 2.0 LACTOSORB SYSTEM 915-2112Screw, fixation, bone1 report
- 2.0 LACTOSORB SYSTEM 915-2300Screw, fixation, bone1 report
- 2.0 LACTOSORB SYSTEM 915-2301-EAScrew, fixation, bone1 report
- 2.0 LactoSorb System 915-2308-EAScrew, fixation, bone1 report
Recent 2.0 LACTOSORB SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Contamination /Decontamination Problem
IT WAS REPORTED DURING INSPECTION AT THE DISTRIBUTORSHIP, A HAIR-LIKE SUBSTANCE WAS FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25587421 ↗MalfunctionJun 4, 2026Packaging Problem
IT WAS REPORTED DURING INSPECTION AT THE DISTRIBUTORSHIP, THAT A HAIR-LIKE SUBSTANCE WAS FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393751 ↗InjuryMar 2, 2026Break; Fracture; Material Deformation
IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE FLAP COLLAPSE NECESSITATING A SECOND CRANIOTOMY. DURING THE REOPERATION, INTRAOPERATIVE FINDINGS INCLUDED SEVERE DEFORMATION OF THE LEFT UPPER CONNECTOR PLATE AND COMPLETE FRACTURE OF THE LEFT LOWER CONNECTOR PLATE. THE SCREWS REMAINED INTACT, AND ONLY THE FOUR-HOLE CONNECTOR PLATE WAS DAMAGED. THE PATIENT HAD NO HISTORY OF TRAUMA, AND THE PROSTHESIS WAS NOT RESHAPED USING A WATER BATH DURING THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Loss of fracture reduction
MAUDE report 24484441 ↗InjuryMar 2, 2026Break; Material Deformation
IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE FLAP COLLAPSE NECESSITATING A SECOND CRANIOTOMY. DURING THE REOPERATION, INTRAOPERATIVE FINDINGS INCLUDED SEVERE DEFORMATION OF THE LEFT UPPER CONNECTOR PLATE AND COMPLETE FRACTURE OF THE LEFT LOWER CONNECTOR PLATE. THE SCREWS REMAINED INTACT, AND ONLY THE FOUR-HOLE CONNECTOR PLATE WAS DAMAGED. THE PATIENT HAD NO HISTORY OF TRAUMA, AND THE PROSTHESIS WAS NOT RESHAPED USING A WATER BATH DURING THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Loss of fracture reduction
MAUDE report 24484419 ↗MalfunctionDec 8, 2025Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742132 ↗InjuryAug 25, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 WEEK POST IMPLANTATION DUE TO PLATE FRACTURE AND MANDIBULAR FRACTURE SEPARATION AND DISPLACEMENT. THE PLATE WAS REPLACED WITH TITANIUM PLATING WITH NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Loss of Range of Motion; Loss of fracture reduction
MAUDE report 22882746 ↗MalfunctionJun 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE POTENTIALLY NON-CONFORMING WITH A HAIR-LIKE SUBSTANCE WITHIN THE PACKAGING. NO PATIENT OR CUSTOMER WAS INVOLVED IN THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22360391 ↗MalfunctionJun 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE POTENTIALLY NON-CONFORMING WITH A HAIR-LIKE SUBSTANCE WITHIN THE PACKAGING. NO PATIENT OR CUSTOMER WAS INVOLVED IN THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22360364 ↗MalfunctionMar 25, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687495 ↗MalfunctionDec 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IT IS REPORTED THAT THE SURGEON USED A 7MM SCREW AFTER PERFORMING THE DRILLING AND TAPPING AS USUAL, BUT COULD NOT FIX THE SCREW CORRECTLY. HE THEN SWITCHED TO AN EMERGENCY SCREW, BUT IT DID NOT REACH THE PLANNED POSITION, AND THIS EMERGENCY SCREW ALSO FAILED TO FIXATE CORRECTLY. THEREFORE, THE SURGEON DECIDED TO SWITCH TO A TITANIUM PLATE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048215 ↗MalfunctionDec 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IT IS REPORTED THAT THE SURGEON USED A 7MM SCREW AFTER PERFORMING THE DRILLING AND TAPPING AS USUAL, BUT COULD NOT FIX THE SCREW CORRECTLY. HE THEN SWITCHED TO AN EMERGENCY SCREW, BUT IT DID NOT REACH THE PLANNED POSITION, AND THIS EMERGENCY SCREW ALSO FAILED TO FIXATE CORRECTLY. THEREFORE, THE SURGEON DECIDED TO SWITCH TO A TITANIUM PLATE TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048208 ↗MalfunctionJul 23, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19805592 ↗MalfunctionMay 14, 2024Positioning Problem; Positioning Problem
IT WAS REPORTED THAT DURING SURGERY, THE HEX HEAD OF THE SCREWS DID NOT BREAK PROPERLY AND THE SCREWS CONTINUED TO SPIN IN THE BONE. THERE WAS A DELAY OF 40 MINUTES AS THE SCREWS WERE REMOVED AND THE SURGERY WAS COMPLETED WITH OTHER PRODUCT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 19312331 ↗MalfunctionMay 14, 2024Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem
IT WAS REPORTED THAT DURING SURGERY, THE HEX HEAD OF THE SCREWS DID NOT BREAK PROPERLY AND THE SCREWS CONTINUED TO SPIN IN THE BONE. THERE WAS A DELAY OF 40 MINUTES AS THE SCREWS WERE REMOVED AND THE SURGERY WAS COMPLETED WITH OTHER PRODUCT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 19312320 ↗MalfunctionMay 14, 2024Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem
IT WAS REPORTED THAT DURING SURGERY, THE HEX HEAD OF THE SCREWS DID NOT BREAK PROPERLY AND THE SCREWS CONTINUED TO SPIN IN THE BONE. THERE WAS A DELAY OF 40 MINUTES AS THE SCREWS WERE REMOVED AND THE SURGERY WAS COMPLETED WITH OTHER PRODUCT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 19312265 ↗
Other Biomet Microfixation, Inc products
- TMJ SYSTEM36 models · 458 reports
- "1.5MM" SYSTEM35 models · 224 reports
- STERNALOCK BLU SYSTEM31 models · 122 reports
- TRAUMAONE SYSTEM39 models · 80 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.
How reports and recalls are matched · Editorial policy · Report an error on this page