Lapiplasty SpeedPlate SK50Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00810111221788), received between Jan 19, 2024 and Aug 6, 2026 — classified as 57 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 59 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 25170990 ↗
• InjuryApr 29, 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 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 25028385 ↗
• InjuryApr 29, 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 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 25028372 ↗
• InjuryMar 31, 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 RECENT REVISION SURGERY DUE TO PAIN, SWELLING, LOOSENED AND BROKEN HARDWARE. THE REVISION SURGERY WAS APPROXIMATELY THREE WEEKS PRIOR TO ON (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 24743384 ↗
• InjuryMar 31, 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 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 24743370 ↗
• InjuryMar 25, 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 IRRITATION. THE PATIENT'S JOINT WAS NOT FULLY 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 24690362 ↗
• InjuryMar 6, 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 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 24533646 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  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 24450002 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, A TWO-TINE STAPLE AND FOUR-TINE STAPLE WERE TO BE REMOVED ON (B)(6) 2026 DUE TO DORSAL SOFT TISSUE IRRITATION. THE TWO-TINE STAPLE WAS REMOVED. HOWEVER, THE SURGEON WAS UNABLE TO REMOVE THE FOUR-TINE STAPLE IN ITS ENTIRETY. THREE OF THE FOUR TINES REMAIN IMPLANTED. 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 24304062 ↗
• InjuryJan 26, 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 ON (B)(6) 2026 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 24177092 ↗
• InjuryJan 26, 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 ON (B)(6) 2026 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 24177088 ↗
• InjuryDec 30, 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) 2025, HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO NONUNION AND PAIN. THE DORSAL SPEEDPLATE HAD BACKED OUT. THERE WAS NO LOSS OF CORRECTION AND THE PATIENT ONLY EXPERIENCED PAIN WHEN PALPATING DORSAL SIDE OF FOOT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 23929202 ↗
• InjuryOct 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NONUNION. ADDITIONAL INFORMATION INDICATES THE PATIENT ALSO HAD NEUROPATHY. 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 23432795 ↗
• InjuryOct 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NONUNION. ADDITIONAL INFORMATION INDICATES THE PATIENT ALSO HAD NEUROPATHY. 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 23432782 ↗
• InjuryAug 20, 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, HARDWARE WAS REMOVED AND REPLACED DURING A REVISION ON (B)(6) 2025 DUE TO NONUNION. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22849783 ↗
• 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 DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO AN ELEVATED FIRST METATARSAL. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED WITH ANY TMC DEVICE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Malunion of Bone

  MAUDE report 22804355 ↗
• 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) 2025 , ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A BROKEN TOE AND THE PATIENT BEING UNSATISFIED WITH THE ORIGINAL CORRECTION. 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 21940377 ↗
• 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 REVISED 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 21704529 ↗