2.0 LACTOSORB SYSTEM 915-2111Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841036054564), received between Mar 19, 2020 and Mar 2, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K955729, K971870); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Break; Fracture; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE FLAP COLLAPSE NECESSITATING A SECOND CRANIOTOMY. DURING THE REOPERATION, INTRAOPERATIVE FINDINGS INCLUDED SEVERE DEFORMATION OF THE LEFT UPPER CONNECTOR PLATE AND COMPLETE FRACTURE OF THE LEFT LOWER CONNECTOR PLATE. THE SCREWS REMAINED INTACT, AND ONLY THE FOUR-HOLE CONNECTOR PLATE WAS DAMAGED. THE PATIENT HAD NO HISTORY OF TRAUMA, AND THE PROSTHESIS WAS NOT RESHAPED USING A WATER BATH DURING THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of fracture reduction

  MAUDE report 24484441 ↗
• InjuryMar 2, 2026Break; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY 12 DAYS POST-IMPLANTATION, THE PATIENT EXPERIENCED BONE FLAP COLLAPSE NECESSITATING A SECOND CRANIOTOMY. DURING THE REOPERATION, INTRAOPERATIVE FINDINGS INCLUDED SEVERE DEFORMATION OF THE LEFT UPPER CONNECTOR PLATE AND COMPLETE FRACTURE OF THE LEFT LOWER CONNECTOR PLATE. THE SCREWS REMAINED INTACT, AND ONLY THE FOUR-HOLE CONNECTOR PLATE WAS DAMAGED. THE PATIENT HAD NO HISTORY OF TRAUMA, AND THE PROSTHESIS WAS NOT RESHAPED USING A WATER BATH DURING THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of fracture reduction

  MAUDE report 24484419 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION AND INFLAMMATION WERE DISCOVERED NINE (9) DAYS FOLLOWING IMPLANTATION OF PLATES AND SCREWS AND A REMOVAL WAS PLANNED TWO (2) WEEKS FOLLOWING IMPLANTATION. THE SURGEON IS UNCERTAIN AS TO THE CAUSE OF THE INFECTION AND THINKS IT IS POSSIBLE THAT THE PLATES AND SCREWS ARE THE CAUSE OF THE INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11086856 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION AND INFLAMMATION WERE DISCOVERED NINE (9) DAYS FOLLOWING IMPLANTATION OF PLATES AND SCREWS AND A REMOVAL WAS PLANNED TWO (2) WEEKS FOLLOWING IMPLANTATION. THE SURGEON IS UNCERTAIN AS TO THE CAUSE OF THE INFECTION AND THINKS IT IS POSSIBLE THAT THE PLATES AND SCREWS ARE THE CAUSE OF THE INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 11086853 ↗
• 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 9853284 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955729, K971870. One submission often covers many models, so check the product and lot details in each record.

• Z-1872-2008 · Mar 19, 2008 · Terminated
  Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and CP-1323. The system is used in trauma and reconstructive su