Lapiplasty System S4A SK39Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00853114006327), received between Jun 14, 2022 and Jun 4, 2026 — classified as 60 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE SURGEON REMOVED ALL HARDWARE ON (B)(6) 2026 DUE TO NERVE ENTRAPMENT. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. 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: Physical Entrapment

  MAUDE report 25391713 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO HARDWARE IRRITATION. 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 24662749 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED ON (B)(6) 2026 DUE TO PAIN. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 24579002 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INITIAL BILATERAL BUNION SURGERIES ON (B)(6) 2024 AND (B)(6) 2024, THE DORSAL PLATE AND FOUR SCREWS WERE REMOVED FROM EACH FOOT ON (B)(6) 2026 DUE TO DISCOMFORT DURING YOGA POSES. 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: Discomfort

  MAUDE report 24313528 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INITIAL BILATERAL BUNION SURGERIES ON (B)(6) 2024, THE DORSAL PLATE AND FOUR SCREWS WERE REMOVED FROM EACH FOOT ON (B)(6) 2026 DUE TO DISCOMFORT DURING YOGA POSES. 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: Discomfort

  MAUDE report 24313503 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO PAIN AND SWELLING. THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. 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; Swelling/ Edema

  MAUDE report 24117202 ↗
• InjuryOct 15, 2025Adverse 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) 2024, THE DORSAL AND MEDIAL PLATES WERE REMOVED ON (B)(6) 2025 DUE TO DORSAL PAIN AT THE TMT JOINT. THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 23283971 ↗
• InjuryAug 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO HARDWARE PAIN AND DISCOMFORT AT THE PLANTAR AND DORSAL MIDFOOT. THE SCREWS WERE BACKING OUT SLIGHTLY AND THERE WAS HYPERTROPHIC BONE FORMATION AROUND THE HARDWARE CAUSING PAIN AT THE FIRST TMT INCISION. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 22926902 ↗
• InjuryJul 5, 2025Adverse 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) 2025 DUE TO HARDWARE PROMINENCE AND SOFT TISSUE IRRITATION. NO DEFICIENCIES OR MALFUNCTIONS WERE 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 22406884 ↗
• InjuryApr 30, 2025Adverse 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) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO SOFT TISSUE IRRITATION. NO DEFICIENCIES OR MALFUNCTIONS WERE 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 21940283 ↗
• InjuryMar 14, 2025Adverse 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) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A FRACTURED MEDIAL CUNEIFORM AND SMASHED PROXIMAL MEDIAL METATARSAL BASE. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21610799 ↗
• InjuryDec 8, 2024Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO A BROKEN DORSAL PLATE AND A BROKEN SCREW. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875194 ↗
• InjuryNov 21, 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO HARDWARE IRRITATION. NO DEFICIENCIES OR MALFUNCTIONS WERE 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 20754850 ↗
• InjuryNov 19, 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. ALL HARDWARE WAS REMOVED ON (B)(6) 2024, DUE TO EXTENSOR TENDON IRRITATION. 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 20719628 ↗
• InjuryOct 24, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAINFUL HARDWARE. 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 20527870 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, THE PATIENT IS EXPERIENCING SWELLING IN THE ARCH AREA. CT IMAGES FROM A POST-OP FOLLOW-UP SHOW A NON-UNION AND TWO BROKEN SCREWS. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE CURRENTLY REMAINS IMPLANTED. ALTHOUGH THERE HAS BEEN NO INJURY REPORTED AND THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE, 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: Nonunion/Delayed-union Bone Fracture; Pain; Swelling/ Edema

  MAUDE report 20467826 ↗
• InjurySep 17, 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) 2024, ALL HARDWARE WAS REMOVED AND REVISED ON (B)(6) 2024 DUE TO LOSS OF CORRECTION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243076 ↗
• InjuryAug 22, 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) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO SOFT TISSUE IRRITATION CAUSED BY PLATE PROMINENCE. 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 20044694 ↗
• InjuryAug 5, 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) 2023, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2024, DUE TO PAIN AT THE TMT. 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 19914645 ↗
• InjuryAug 5, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO DISCOMFORT. 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: Discomfort

  MAUDE report 19914640 ↗
• InjuryJul 8, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 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 19696482 ↗
• InjuryJun 27, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PROMINENT HARDWARE THAT BOTHERED THE PATIENT WHEN WEARING SHOES. 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: Discomfort

  MAUDE report 19630666 ↗
• InjuryMay 21, 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) 2024, HARDWARE WAS REMOVED ON (B)(6)2024 DUE TO PAIN AROUND THE DORSAL 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: Pain

  MAUDE report 19368273 ↗
• InjuryMay 10, 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 PAIN. 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 19283344 ↗
• InjuryMay 7, 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAINFUL HARDWARE. 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 19264214 ↗