Lapiplasty SK18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00853114006068), received between Jun 24, 2021 and Jul 3, 2024 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A REVISION OF A DISTAL OSTEOTOMY SURGERY ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO NON-UNION OF THE FIRST TMT JOINT. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19672541 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO IRRITATION FROM THE MEDIAL PLATE. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19222014 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INITIAL BILATERAL BUNION SURGERIES, ALL HARDWARE FROM BOTH FEET WAS REMOVED ON (B)(6) 2023 DUE TO PAIN AT THE HARDWARE SITE. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 18499923 ↗
• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT A SCREW BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. A BACK-UP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE CASE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALTHOUGH THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE IN THIS EVENT, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, A MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18062598 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, A BROKEN SCREW WAS DISCOVERED POST-SURGERY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17977023 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO NON-UNION. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17795746 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO A POST-OP ACQUIRED INFECTION. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17674545 ↗
• InjuryJul 27, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO NONUNION, A BROKEN PLATE AND BROKEN SCREW. THE TIP OF THE BROKEN SCREW WAS RETAINED IN THE PATIENT'S BONE. THE SITE WAS REVISED WITH NON-TMC HARDWARE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17407164 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN. UPON REMOVAL, THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 17015357 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2021, HARDWARE (TMC DEVICES: 8 SCREWS, 2 PLATES, INTERFRAG SCREW AND TRANSVERSE SCREW; NON-TMC DEVICE: HEADLESS SCREW) WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2022 DUE TO PAIN. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 15655982 ↗
• InjuryMay 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2021, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2022 DUE TO IRRITATION AND PAIN. UPON REMOVAL, THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 14403481 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2019, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY DUE TO WHAT THE PATIENT BELIEVED WAS HER "BODY REJECTING IT." NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE CONFIRMING THE PATIENT HAS A METAL ALLERGY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 12641819 ↗
• InjuryJun 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2021 DUE TO LOOSE HARDWARE AND A PAINFUL NON-UNION. THE SURGEON BELIEVES THE PATIENT "WALKED TOO SOON" RESULTING IN A PLANTAR GAP AT THE TMT JOINT. UPON REMOVAL THE PLATES WERE ALSO DISCOVERED TO BE BENT AND THE SITE WAS REVISED WITH NEW TMC HARDWARE.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 12063365 ↗