2.0 LactoSorb System 915-2301-EA (UDI 00888233025232)Recalls & reported problems
Biomet Microfixation, Inc · Class 2 · Implant
All models of 2.0 LACTOSORB SYSTEM (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888233025232), received between Jan 31, 2022 and May 14, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Positioning Problem” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Problem2
- Output Problem1
- Positioning Failure1
Patient problems
- Failure of Implant2
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryJan 31, 2022Output Problem
IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE UNDER LOCAL ANESTHESIA APPROXIMATELY TWO MONTHS POST-IMPLANTATION DUE TO DRAINAGE AND PLATE EXPOSURE FROM THE ORAL VESTIBULE.
Patient problems: Wound Dehiscence
MAUDE report 13401673 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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