2.0 LACTOSORB SYSTEM 915-2151Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036054670), received between Mar 19, 2020 and May 26, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Unexpected Therapeutic Results

  IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PLATE EXPOSURE WHILE SUFFERING FROM SINUSITIS. THE PATIENT IS NOT INFECTED, AND THE SIZE OF THE EXPOSURE WAS ABOUT 1.5 CM X 1.5 CM. THE WOUND WAS LEFT OPEN TO ASSIST IN TREATMENT OF THE SINUSITIS. THE PATIENT IS SCHEDULED TO HAVE THE EXPOSED AREA CLOSED AT A LATER DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Impaired Healing; Skin Tears; Swelling/ Edema

  MAUDE report 14515788 ↗
• 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 13402015 ↗
• InjuryJun 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED A RE-OPERATION WAS PERFORMED DUE TO PLATE EXPOSURE FIVE (5) MONTHS FOLLOWING IMPLANTATION. THE PLATE HAD BEEN IMPLANTED ON THE MAXILLA AT A ZYGOMATIC FRACTURE DURING AN OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE AND FIVE (5) MONTHS LATER THE CORNER OF THE PLATE WAS EXPOSED. NO INFECTION WAS REPORTED TO HAVE OCCURRED AND THE PLATE WAS REMOVED IN A REVISION. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10115321 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE (3) BIO-ABSORBABLE PLATES WERE REMOVED DUE TO INFECTION APPROXIMATELY TWO (2) WEEKS FOLLOWING IMPLANTATION DURING A MIDFACE RECONSTRUCTION PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9853312 ↗