Lapiplasty SpeedPlateRecalls & reported problems across all models
Treace Medical Concepts, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 113
- Deaths reported
- 0
- Injuries reported
- 110
- Recalls
- 0
We found 5 models of Lapiplasty SpeedPlate by Treace Medical Concepts, Inc. in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2024 and Aug 6, 2026 — classified as 110 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Lapiplasty SpeedPlate problems
Device problems
- Adverse Event Without Identified Device or Use Problem102
- Loosening of Implant Not Related to Bone-Ingrowth10
- Break2
Patient problems
- Nonunion/Delayed-union Bone Fracture35
- Pain21
- Skin Inflammation/ Irritation19
- No Clinical Signs, Symptoms or Conditions12
- Swelling/ Edema10
- Hypersensitivity/Allergic reaction6
- Bone Fracture(s)5
- Malunion of Bone4
Lapiplasty SpeedPlate models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Lapiplasty SpeedPlate SK50Staple, Fixation, Bone59 reports
- Lapiplasty SpeedPlate SK51Staple, Fixation, Bone35 reports
- Lapiplasty SpeedPlate SK53Staple, Fixation, Bone11 reports
- Lapiplasty SpeedPlate SK52Staple, Fixation, Bone7 reports
- Lapiplasty SpeedPlate SK47Staple, Fixation, Bone1 report
Recent Lapiplasty SpeedPlate adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50163209 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that after an initial bunion surgery, all 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 50161500 ↗InjuryAug 3, 2026Break
It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed on (b)(6) 2026 due to non-union and a broken staple. No other patient outcomes were reported as a result of this event.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 50113432 ↗InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO LOSS OF CORRECTION AFTER THE PATIENT EXPERIENCED A POST-OP FALL. 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: Fall
MAUDE report 25620391 ↗InjuryJun 23, 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 PAIN AT THE DORSAL PLATE. 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
MAUDE report 25592849 ↗InjuryJun 5, 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 25414919 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED (B)(6) 2026 DUE TO NUMBNESS. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Numbness
MAUDE report 25381192 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY; ALL HARDWARE WAS REMOVED (B)(6) 2026 DUE TO NUMBNESS. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Numbness
MAUDE report 25380879 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE DORSAL PLATE WAS REMOVED ON (B)(6) 2026 DUE TO EHL IRRITATION. THE SURGEON ATTEMPTED TO REMOVE THE MEDIAL PLATE BUT ELECTED TO LEAVE IT IN DUE TO OPERATIVE TIME CONSTRAINTS. ADDITIONAL INFORMATION INDICATES THAT 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: Skin Inflammation/ Irritation
MAUDE report 25322847 ↗InjuryMay 28, 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 SWELLING. UPON REMOVAL, THERE WERE NO DEFICIENCIES OR MALFUNCTIONS FOUND WITH ANY TMC DEVICE AND THE PATIENT'S BONES WERE COMPLETELY FUSED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Swelling/ Edema
MAUDE report 25317961 ↗InjuryMay 28, 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 SWELLING. UPON REMOVAL, THERE WERE NO DEFICIENCIES OR MALFUNCTIONS FOUND WITH ANY TMC DEVICE AND THE PATIENT'S BONES WERE COMPLETELY FUSED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Swelling/ Edema
MAUDE report 25315193 ↗InjuryMay 28, 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 SWELLING. UPON REMOVAL, THERE WERE NO DEFICIENCIES OR MALFUNCTIONS FOUND WITH ANY TMC DEVICE AND THE PATIENT'S BONES WERE COMPLETELY FUSED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Swelling/ Edema
MAUDE report 25314943 ↗InjuryMay 28, 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 SWELLING. UPON REMOVAL, THERE WERE NO DEFICIENCIES OR MALFUNCTIONS FOUND WITH ANY TMC DEVICE AND THE PATIENT'S BONES WERE COMPLETELY FUSED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Swelling/ Edema
MAUDE report 25314789 ↗InjuryMay 20, 2026Break
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 25236750 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2026 DUE TO HARDWARE IRRITATION AND 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 25171840 ↗
Other Treace Medical Concepts, Inc. products
All Treace Medical Concepts, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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