Lapiplasty SK19Recalls & reported problems
Treace Medical Concepts, Inc. · 3.5mm Transverse Screw · Class 2 · Implant
Quick summary
This Treace Medical Concepts Lapiplasty SK19 bone fixation screw is used in bunion surgery to hold plates in place. Most of the 48 reports describe pain after surgery, bone that did not heal, and skin irritation; a few describe screws or plate tines breaking, loosening, or needing removal during revision surgery. There are 47 injuries and no deaths. No recalls name this device, and the number of reports is unchanged over the past year.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00853114006075), received between Jul 31, 2020 and Aug 5, 2026 — classified as 47 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (4 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 Problem44
- Break4
- Migration or Expulsion of Device1
Patient problems
- Pain26
- Nonunion/Delayed-union Bone Fracture9
- No Clinical Signs, Symptoms or Conditions4
- Skin Inflammation/ Irritation4
- Swelling/ Edema3
- Bacterial Infection2
- Unspecified Infection2
- Foreign Body Reaction1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
It was reported that after an initial bunion surgery, 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 50145383 ↗InjuryMay 20, 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 DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO NONUNION AND BROKEN PLATE TINES. TWO TINES (INNER PROXIMAL AND INNER DISTAL) ON THE DORSAL QUAD PLATE WERE BROKEN. THE SURGEON REMOVED THE INNER PROXIMAL TINE, BUT THE INNER DISTAL TINE REMAINS IMPLANTED AS THE SURGEON WAS UNABLE TO REMOVE IT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 25236760 ↗InjuryFeb 25, 2026Break; 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 AND REPLACED DURING A RECENT REVISION SURGERY DUE TO PAIN, SWELLING, LOOSENED AND BROKEN HARDWARE. THE REVISION SURGERY WAS APPROXIMATELY THREE WEEKS PRIOR TO (B)(6) 2026, HOWEVER THE EXACT DATE IS UNKNOWN. THE HARDWARE HAD LOOSENED AND A BROKEN SCREW WAS DISCOVERED VIA RADIOGRAPHIC IMAGE DURING A POST-OP FOLLOW-UP. THE PATIENT REPORTED THAT SHE SUBSEQUENTLY DEVELOPED HAMMER TOES OF THE 2ND, 3RD, AND 4TH TOES, AND EXPERIENCED PAIN WHEN PUTTING ON SHOES AND IF ON THE FOOT FOR MORE THAN AN HOUR. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain; Swelling/ Edema
MAUDE report 24450010 ↗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 22406885 ↗InjuryJan 31, 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 21287621 ↗InjuryNov 15, 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 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 20701122 ↗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 19188757 ↗InjuryApr 9, 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) 2021, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAIN 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: Pain
MAUDE report 19076813 ↗InjuryFeb 29, 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. 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 18813513 ↗InjuryJan 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 IN (B)(6) 2022, ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO PROMINENCE OF THE DORSAL PLATE THAT WAS DISCOVERED VIA RADIOGRAPHIC IMAGING. 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 18528514 ↗InjuryJan 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 ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO PAIN AROUND THE 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 18438250 ↗InjuryDec 28, 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 ON (B)(6) 2021 DUE TO PAIN IN THE IMPLANT AREA. 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 18416272 ↗InjuryDec 28, 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 AND REPLACED ON (B)(6) 2023 DUE TO NONUNION OF THE JOINT AND INTRACUNEIFORM FRACTURE OF THE MEDIAL CUNEIFORM. 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 18416245 ↗InjuryDec 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) 2022, 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 18252906 ↗InjuryOct 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, A TRANSVERSE SCREW WAS REMOVED ON (B)(6) 2023 DUE TO THE SCREW BACKING OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17927683 ↗InjuryOct 5, 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. ACCORDING TO THE SURGEON, CLINICAL SETTING FACTORS DURING THE INITIAL BUNION SURGERY RESULTED IN AN INABILITY TO ACHIEVE APPROPRIATE CORRECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17878503 ↗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 8/23/2023 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 17795748 ↗InjurySep 8, 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 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 17715665 ↗InjuryAug 25, 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 PAINFUL HARDWARE AND MALUNION. 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 17626164 ↗InjuryJul 14, 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 NONUNION. THE SITE WAS REVISED WITH NON-TMC HARDWARE. 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: Nonunion/Delayed-union Bone Fracture
MAUDE report 17323985 ↗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 17015356 ↗InjuryMay 12, 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 IN A REVISION SURGERY ON (B)(6) 2023 DUE TO NONUNION AND PAIN. THE SITE WAS REVISED WITH TMC HARDWARE. 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: Nonunion/Delayed-union Bone Fracture; Pain
MAUDE report 16924948 ↗InjuryMay 12, 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 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 16924934 ↗InjuryMay 5, 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 AND 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: Pain; Unspecified Infection
MAUDE report 16882782 ↗InjuryMar 10, 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, THE HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO IRRITATION. 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: Skin Inflammation/ Irritation
MAUDE report 16525989 ↗
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- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-375Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.