Lapiplasty System 1 SK12Recalls & reported problems
Treace Medical Concepts, Inc. · Anatomic Biplanar Fixation · Class 2 · Implant
Quick summary
The Lapiplasty System from Treace Medical Concepts is a set of plates and screws used to correct bunion surgery. The 31 reports mostly describe irritation of the skin around the implant, pain, and bones that fail to knit together after surgery, sometimes leading to a second operation to remove or replace the hardware. Eight reports mention a broken implant. There were 30 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00810111221337), received between Jun 27, 2024 and Sep 28, 2026 — classified as 32 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (8 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Break8
Patient problems
- Skin Inflammation/ Irritation13
- Nonunion/Delayed-union Bone Fracture9
- Pain9
- No Clinical Signs, Symptoms or Conditions3
- Discomfort2
- Hypersensitivity/Allergic reaction1
- Malunion of Bone1
- Post Operative Wound Infection1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50914356 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that after an initial bunion surgery on (b)(6) 2021, hardware was removed on (b)(6) 2026 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 50914283 ↗InjuryApr 29, 2026Adverse 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) 2026 DUE TO SOFT TISSUE 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 25031958 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED ON (B)(6) 2026 DUE TO SOFT TISSUE IRRITATION. 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: Skin Inflammation/ Irritation
MAUDE report 25000880 ↗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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO NON-UNION OF THE TMT JOINT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 24661274 ↗InjuryMar 20, 2026Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED AND REPLACED WITH NON-TMC DEVICES DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO BROKEN DORSAL PLATE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651879 ↗InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED AND REPLACED WITH A NON TMC DEVICE DURING A REVISION SURGERY ON (B)(6) 2026 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 24581971 ↗InjuryMar 11, 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO NONUNION. THE SITE WAS REVISED WITH NON-TMC 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: Nonunion/Delayed-union Bone Fracture
MAUDE report 24572069 ↗InjuryDec 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) 2025 ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO NONUNION. ADDITIONAL INFORMATION INDICATES THE PATIENT WAS NON-COMPLIANT. THE SITE WAS REVISED WITH NON-TMC 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: Nonunion/Delayed-union Bone Fracture
MAUDE report 23924952 ↗InjuryDec 11, 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NONUNION. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/ FOUND WITH ANY TMC DEVICE.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 23781870 ↗InjuryAug 21, 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) 2022, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO ELEVATUS AND PAIN AT THE TMT (TARSOMETATARSAL) AND MTP (METATARSOPHALANGEAL) JOINTS. 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: Malunion of Bone; Pain
MAUDE report 22861452 ↗InjuryAug 13, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO PLANTAR DISCOMFORT. 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: Discomfort
MAUDE report 22794987 ↗InjuryJul 1, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED AND REPLACED DURING REVISION SURGERY ON (B)(6) 2025 DUE TO NON-UNION. DURING THE HARDWARE REMOVAL, A BROKEN SCREW WAS DISCOVERED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 22371011 ↗InjuryMay 26, 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) 2018, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO THE PATIENT COMPLAINING OF FEELING THE PLATES WHEN WEARING SHOES. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 22085298 ↗InjuryMay 12, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY IN (B)(6) 2024, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO DISCOMFORT, NONUNION, AND A BROKEN DORSAL LATERAL PLATE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort; Nonunion/Delayed-union Bone Fracture
MAUDE report 22007593 ↗InjuryMay 7, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO PAIN, NON-UNION AND A BROKEN PLATE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 21982214 ↗InjuryMay 6, 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 TENDON 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 21973732 ↗InjuryNov 5, 2024Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, THE THIRD TMT PLATE WAS REMOVED ON (B)(6) 2024 DUE TO SOFT TISSUE IRRITATION. UPON REMOVAL OF THE PLATE, ONE SCREW WAS NOTED TO BE POKING OUT OF THE PATIENT'S SKIN AND TWO SCREWS WERE FOUND TO BE BROKEN, ALL THE SCREWS WERE REMOVED AS WELL. THE SECOND TMT PLATE AND SCREWS WERE LEFT IN PLACE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 20614260 ↗InjuryOct 21, 2024Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED AND REPLACED IN A REVISION SURGERY ON (B)(6) 2024 DUE TO NON-UNION AND A BROKEN PLATE THAT WAS DISCOVERED VIA RADIOGRAPHIC IMAGE FROM A POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 20500336 ↗InjuryOct 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 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 20477219 ↗InjuryOct 3, 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 OF THE LEFT FOOT ON (B)(6) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO IRRITATION AT THE TENDON. 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 20365087 ↗InjuryOct 3, 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 OF THE RIGHT FOOT ON (B)(6)2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO IRRITATION AT THE TENDON. 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 20365086 ↗InjurySep 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 ON (B)(6) 2022, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO SOFT TISSUE 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 20263957 ↗InjurySep 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO FLUID AROUND THE INCISION INDICATING POSSIBLE 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 20186900 ↗InjuryAug 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 PAINFUL AND PROMINENT 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 20077540 ↗
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- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.