Lapiplasty System 2 SK14Recalls & reported problems
Treace Medical Concepts, Inc. · Anatomic Biplanar Implants · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Lapiplasty System 2 bone plate from Treace Medical is a fixation plate used with screws. Many reports describe plates and screws being removed after bunion surgery because of pain, irritation or a bone that did not heal, and some mention broken screws or fragments left in the body. There are 260 reports, no deaths and 170 injuries. 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
- 260
- Deaths reported
- 0
- Injuries reported
- 170
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00853114006051), received between Nov 27, 2018 and Jun 15, 2026 — classified as 170 injuries, 90 malfunctions.
The most frequently reported specific device problem is “Break” (101 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem146
- Break101
- Loosening of Implant Not Related to Bone-Ingrowth10
- Migration or Expulsion of Device6
- Patient-Device Incompatibility1
Patient problems
- Pain80
- Foreign Body In Patient68
- Nonunion/Delayed-union Bone Fracture38
- Skin Inflammation/ Irritation17
- No Clinical Signs, Symptoms or Conditions13
- Discomfort12
- Device Embedded In Tissue or Plaque10
- No Code Available10
Recent adverse event reports
The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.
InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, TWO PLATES AND 8 SCREWS WERE REMOVED DUE TO MEDIAL 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 25510846 ↗InjuryApr 15, 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 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 24887013 ↗InjuryDec 29, 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 ON (B)(6) 2025 DUE TO PAIN. THERE WAS NO LOSS OF CORRECTION AND THE PATIENT WAS 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 23908514 ↗InjuryDec 8, 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 ON (B)(6) 2025 DUE TO 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 23744505 ↗InjuryAug 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; ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO MEDIAL PLATE DISCOMFORT. 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: Discomfort
MAUDE report 22806923 ↗InjuryMar 27, 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NON-UNION. 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: Nonunion/Delayed-union Bone Fracture
MAUDE report 21704528 ↗InjuryJan 13, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO NON-UNION AND A BROKEN SCREW. A PORTION OF THE BROKEN SCREW REMAINED IN THE CUNEIFORM. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21146430 ↗InjuryNov 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) 2020, 2 PLATES AND 8 SCREWS WERE 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 20765735 ↗InjuryOct 17, 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 DISCOMFORT PRIMARILY DUE TO THE OVERALL FEELING OF THE HARDWARE, AND A BROKEN SCREW 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: Discomfort
MAUDE report 20477290 ↗InjuryOct 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 ON (B)(6) 2019, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO MIDFOOT PAIN AND STIFFNESS AT THE IMPLANT 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 20390486 ↗InjurySep 16, 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 NERVE IRRITATION DORSALLY. 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: Hyperresponsive to stimuli
MAUDE report 20233146 ↗InjurySep 11, 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 RUBBING AND 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 20197413 ↗InjurySep 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 ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 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 20165300 ↗InjuryAug 7, 2024Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth
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, AND BACKED-OUT SCREW. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19931648 ↗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) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO BONE FRACTURE. 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 19630672 ↗InjuryJun 11, 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, THE DORSAL PLATE WAS REMOVED ON (B)(6) 2024 DUE TO IRRITATION. NO OTHER 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 19512989 ↗InjuryJun 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, ALL HARDWARE WAS REMOVED AND REVISED 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 19494304 ↗InjuryJun 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 AND REVISED 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 19492438 ↗InjuryJun 5, 2024Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, THE HARDWARE WAS REMOVED AND REVISED ON (B)(6) 2024 DUE TO PARTIAL NON-UNION AND TWO BROKEN SCREWS. TWO SMALL FRAGMENTS FROM THE BROKEN SCREWS WERE RETAINED IN THE PATIENT'S FOOT AS THEY WERE UNABLE TO BE REMOVED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 19470116 ↗InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A RIGHT INITIAL BUNION SURGERY ON (B)(6) 2019, THE PATIENT UNDERWENT A CORRECTIVE SURGERY DUE TO PAIN AND RECURRENCE. 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 19442953 ↗InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A LEFT INITIAL BUNION SURGERY ON (B)(6) 2019, THE PATIENT UNDERWENT A CORRECTIVE SURGERY DUE TO PAIN AND 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; Pain
MAUDE report 19442906 ↗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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAIN FROM THE DORSAL PLATE WHEN WEARING CERTAIN 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: Pain
MAUDE report 19226034 ↗InjuryApr 25, 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 A NON-HEALING DORSAL WOUND. 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: Impaired Healing
MAUDE report 19188756 ↗InjuryApr 25, 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 A NON-HEALING DORSAL WOUND. 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: Impaired Healing
MAUDE report 19188754 ↗InjuryApr 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 PAIN AND 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; Pain
MAUDE report 19150096 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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