LACTOSORB 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
- 21
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 7 models of LACTOSORB SYSTEM by Biomet Microfixation, Inc in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 4, 2019 and Jul 14, 2026 — classified as 5 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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 LACTOSORB SYSTEM problems
Device problems
- Fracture15
- Device-Device Incompatibility4
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient5
- Bone Fracture(s)1
- No Information1
LACTOSORB SYSTEM models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LACTOSORB SYSTEM 915-0020PLATE, BONE10 reports
- LACTOSORB® SYSTEM 915-2451SCREWDRIVER4 reports
- LACTOSORB SYSTEM 915-2336Screw, Fixation, Bone2 reports
- LACTOSORB® SYSTEM 915-1595TAP, BONE2 reports
- LACTOSORB SYSTEM 915-2822PLATE, BONE1 report
- LACTOSORB® SYSTEM 915-1595TAP, BONE1 report
- LactoSorb System 915-2822PLATE, BONE1 report
Recent LACTOSORB SYSTEM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Contamination /Decontamination Problem
IT WAS REPORTED THAT DURING INSPECTION AT THE DISTRIBUTORSHIP, IT WAS DISCOVERED THERE WAS A HAIR-LIKE SUBSTANCE WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25815520 ↗InjuryDec 14, 2022Fracture; Fracture
IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15979494 ↗MalfunctionDec 14, 2022Fracture; Fracture
IT IS REPORTED THAT THE SCREWS FRACTURED DURING IMPLANTATION DURING A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15978799 ↗MalfunctionDec 14, 2022Fracture; Fracture
IT IS REPORTED THAT THE SCREWS FRACTURED DURING IMPLANTATION DURING A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15978742 ↗InjuryDec 14, 2022Fracture; Fracture
IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15977541 ↗InjuryDec 14, 2022Fracture; Fracture
IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15977511 ↗MalfunctionApr 9, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641298 ↗MalfunctionApr 9, 2021Fracture; Component Missing; Fracture; Component Missing
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11640737 ↗MalfunctionApr 9, 2021Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANT WAS FOUND FRACTURED UPON OPENING THE PACKAGE APPROXIMATELY TWO (2) YEARS AND TWO (2) MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11640679 ↗MalfunctionJan 5, 2021Fracture; Fracture
IT WAS REPORTED THE TAP BROKE WHILE THE SURGEON WAS CUTTING THE TAP RESULTING IN A SURGICAL DELAY GREATER THAN THIRTY MINUTES. THE SURGEON DRILLED A HOLE AROUND THE BROKEN TAP WITH A TWIST DRILL AND USED PLIERS TO REMOVE THE TAP. IMAGING REVEALED THERE WAS NO FRAGMENT IN THE PATIENT'S BODY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 11121466 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529187 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED, AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529117 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529111 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE BLADE COULD NOT RETAIN SCREWS. FIVE (5) MM SCREWS COULD BE GRASPED AND SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BLADE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10528450 ↗MalfunctionJun 17, 2020Fracture; Fracture
IT WAS REPORTED THE DRILL AND TAP FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DRILL AND TAP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10165558 ↗
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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