2.0 LACTOSORB SYSTEM 915-2201Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
Quick summary
This Biomet MicroFixation LactoSorb bone fixation screw is used to hold tissue in place during surgery. The 28 reports mostly describe screws that would not stay gripped on the screwdriver, screw heads that did not fit tight, screws breaking during placement, and packages found with a hair-like substance inside. No deaths or injuries were reported, and no recalls name this device. There were no reports in the last 12 months, down from 2 in the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00841036054700), received between Aug 24, 2020 and Jun 30, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility17
- Detachment of Device or Device Component9
- Fracture4
- Device Contaminated During Manufacture or Shipping2
- Mechanical Problem2
Patient problems
- No Consequences Or Impact To Patient18
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMay 24, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11871182 ↗MalfunctionMay 24, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11871061 ↗MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED APPROXIMATELY THREE (3) WEEKS AGO THAT A PATIENT UNDERWENT AN INITIAL SEGMENT PROCEDURE. DURING IMPLANTATION, THE SCREWHEAD DID NOT FIT TIGHT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11787198 ↗MalfunctionMay 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11787188 ↗MalfunctionApr 30, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED 2 SCREWS COULD NOT BE GRIPPED AND 1 SCREW BROKE BECAUSE IT WAS TOO TIGHT TO PULL OUT OF THE SCREWDRIVER DURING A MAXILLARY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11753403 ↗MalfunctionApr 29, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT TWO (2) SCREWS COULD NOT BE RETAINED BY THE SCREWDRIVER BLADE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11747685 ↗MalfunctionFeb 8, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11298257 ↗MalfunctionJan 8, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ONE SCREW WAS LOOSE AND DID NOT FIT ON THE SHAFT OF THE BLADE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11140139 ↗MalfunctionJan 5, 2021Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility
IT WAS REPORTED ONE (1) SCREW COULD NOT BE GRIPPED AND ONE (1) SCREW BROKE BECAUSE IT WAS TOO TIGHT TO PULL OUT OF THE SCREWDRIVER DURING A MAXILLARY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCREW. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11121455 ↗MalfunctionJan 5, 2021Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11121453 ↗MalfunctionDec 29, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11086871 ↗MalfunctionDec 21, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11051049 ↗MalfunctionDec 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10999096 ↗MalfunctionDec 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10999084 ↗MalfunctionNov 17, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10856687 ↗MalfunctionOct 13, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10672914 ↗MalfunctionOct 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10671278 ↗MalfunctionSep 22, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10566359 ↗MalfunctionSep 18, 2020Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10552929 ↗MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SCREWS COULD NOT BE RETAINED BY FOUR DIFFERENT BLADES. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10538761 ↗MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Patient Involvement
MAUDE report 10538756 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SCREWS COULD NOT BE GRASPED BY THE BLADE AND THE SCREWS FELL OFF THE BLADE DURING A PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10532248 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SCREWS COULD NOT BE GRASPED BY MULTIPLE BLADES DURING A MAXILLARY LEFORT I OSTEOTOMY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10532241 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-375Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.