LACTOSORB SYSTEM 915-0020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841036053864), received between Mar 24, 2020 and Dec 14, 2022 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K003281); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2022Fracture; Fracture

  IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979494 ↗
• MalfunctionDec 14, 2022Fracture; Fracture

  IT IS REPORTED THAT THE SCREWS FRACTURED DURING IMPLANTATION DURING A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978799 ↗
• MalfunctionDec 14, 2022Fracture; Fracture

  IT IS REPORTED THAT THE SCREWS FRACTURED DURING IMPLANTATION DURING A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978742 ↗
• InjuryDec 14, 2022Fracture; Fracture

  IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977541 ↗
• InjuryDec 14, 2022Fracture; Fracture

  IT IS REPORTED THAT THE SCREWS FRACTURED AFTER THE INITIAL IMPLANTATION AND THE PATIENT HAD TO BE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977511 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641298 ↗
• MalfunctionApr 9, 2021Fracture; Component Missing; Fracture; Component Missing

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640737 ↗
• MalfunctionApr 9, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS FOUND FRACTURED UPON OPENING THE PACKAGE APPROXIMATELY TWO (2) YEARS AND TWO (2) MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640679 ↗
• MalfunctionApr 13, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE BIO-ABSORBABLE CLAMP WAS FOUND FRACTURED BEFORE USE DURING SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9954428 ↗
• MalfunctionMar 24, 2020Fracture; Fracture

  IT WAS REPORTED THE BIO-ABSORBABLE CRANIAL FIXATION CLAMPS FRACTURED INTRA-OPERATIVELY DURING A INFRATENTORIAL CRANIOTOMY. ANOTHER PACK OF BONE CLAMPS WAS OPENED BUT WERE FOUND IN AN UNUSABLE CONDITION. THE FASCIA SUTURES, FIBRIN PATCH AND FIBRIN SEALANT THAT WERE ALREADY IN PLACE WERE REMOVED TO FACILITATE REMOVAL OF THE FRACTURED CRANIAL FIXATION CLAMPS, RESULTING IN A 20 MINUTE DELAY. THE PATIENT WAS CLOSED WITH PDS SUTURES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9872164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003281. One submission often covers many models, so check the product and lot details in each record.

• Z-1705-2018 · Apr 5, 2018 · Terminated
  Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.