Lapiplasty SpeedPlate - MicroQuad SK61Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810111223638), received between Oct 15, 2025 and Jun 25, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 25621240 ↗
• InjuryJun 1, 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 HARDWARE PAIN. 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; Pain

  MAUDE report 25351127 ↗
• InjuryMay 21, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER THE INITIAL BUNION SURGERY ON (B)(6) 2026, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO A LOOSE PLATE AND NON-COMPLIANCE. THERE WERE NO OTHER PATIENT OUTCOMES REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245384 ↗
• 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 25236737 ↗
• 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 24690509 ↗
• 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 ON (B)(6) 2025 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 24663218 ↗
• 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 AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO PAIN. IT WAS NOTED THAT A SPEEDPLATE HAD WORKED ITSELF OUT MEDIALLY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 23921203 ↗
• InjuryOct 15, 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, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO LOSS OF CORRECTION AND THE MEDIAL IMPLANT BEING DISPLACED. THE PATIENT WAS NON-COMPLIANT, FELL DOWN, AND INJURED HER FOOT. UPON REMOVAL OF THE HARDWARE, IT WAS CONFIRMED THE MEDIAL CUNEIFORM WAS FRACTURED. 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 23305644 ↗