2.0 LACTOSORB SYSTEM 915-2200Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of 2.0 LACTOSORB SYSTEM (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841036054687), received between Jun 2, 2020 and Jun 4, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Fracture” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture8
- Detachment of Device or Device Component7
- Difficult to Insert4
- Device-Device Incompatibility2
- Defective Device1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 11787201 ↗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 11787162 ↗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 11786972 ↗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 11786958 ↗MalfunctionMar 8, 2021Fracture; Difficult to Insert; Fracture; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440709 ↗MalfunctionMar 8, 2021Fracture; Difficult to Insert; Fracture; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440681 ↗MalfunctionMar 8, 2021Fracture; Difficult to Insert; Fracture; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440668 ↗MalfunctionMar 8, 2021Fracture; Difficult to Insert; Fracture; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11440621 ↗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 11051030 ↗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 11050061 ↗MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORAL SURGERY, THE SURGEON WAS UNABLE TO GRASP THE SCREW WITH THE DRIVER AND THE SCREW FELL OFF. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10442431 ↗MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN ORAL SURGERY, THE SURGEON WAS UNABLE TO GRASP THE SCREW WITH THE DRIVER AND THE SCREW FELL OFF. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10442243 ↗MalfunctionAug 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE FOR THE CORRECTION OF A JAW DEFORMITY, THE HEAD OF THE SCREW COULD NOT BE GRASPED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10442112 ↗MalfunctionJul 9, 2020Defective Device; Defective Device
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10253326 ↗MalfunctionJun 2, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10112237 ↗MalfunctionJun 2, 2020Fracture; Fracture
IT WAS REPORTED THE SCREW COULD NOT BE USED DUE TO SCREW FRACTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SCREW. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10112223 ↗MalfunctionJun 2, 2020Fracture; Fracture
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10112217 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive 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 STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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