2.0 LACTOSORB SYSTEM 915-2301Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00841036055028), received between May 24, 2019 and Dec 8, 2025 — classified as 27 injuries, 5 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K002083, 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742132 ↗
• MalfunctionDec 31, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT IS REPORTED THAT THE SURGEON USED A 7MM SCREW AFTER PERFORMING THE DRILLING AND TAPPING AS USUAL, BUT COULD NOT FIX THE SCREW CORRECTLY. HE THEN SWITCHED TO AN EMERGENCY SCREW, BUT IT DID NOT REACH THE PLANNED POSITION, AND THIS EMERGENCY SCREW ALSO FAILED TO FIXATE CORRECTLY. THEREFORE, THE SURGEON DECIDED TO SWITCH TO A TITANIUM PLATE TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048208 ↗
• 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 19312265 ↗
• 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 19312194 ↗
• 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 13401667 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDWERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY DUE TO SWELLING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13017946 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY DUE TO SWELLING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013766 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013758 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013714 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Swelling/ Edema

  MAUDE report 13013694 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013681 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY DUE TO SWELLING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013624 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING APPROXIMATELY 8 MONTHS AFTER A PIRIFORM APERTURE WITH LACTOSORB FOR MAXILLARY OSTEOTOMY. THE PATIENT HAS INDICATED FOR A REVISION, ALTHOUGH IT HAS YET TO OCCUR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Swelling/ Edema

  MAUDE report 13013609 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872679 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872651 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872636 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION NINE (9) MONTHS FOLLOWING FIXATION WITH RESORBABLE IMPLANTS AFTER A MAXILLARY OSTEOTOMY OF THE UPPER LEFT JAW. DURING THE RESORPTION STAGE, THE PATIENT¿S GUMS WERE SWOLLEN AND PUS WAS EXCRETED. THE SURGEON IS MONITORING THE PATIENT AND NO REVISION IS PLANNED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872620 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION NINE (9) MONTHS FOLLOWING FIXATION WITH RESORBABLE IMPLANTS AFTER A MAXILLARY OSTEOTOMY OF THE UPPER LEFT JAW. DURING THE RESORPTION STAGE, THE PATIENT¿S GUMS WERE SWOLLEN AND PUS WAS EXCRETED. THE SURGEON IS MONITORING THE PATIENT AND NO REVISION IS PLANNED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872598 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872587 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872567 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872558 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872549 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872544 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872535 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 11872522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002083, 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
• Z-0385-2012 · Feb 17, 2006 · Terminated
  Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL
• Z-0383-2012 · Feb 17, 2006 · Terminated
  Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ S
• Z-0384-2012 · Feb 17, 2006 · Terminated
  Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURG