TMC SpeedMTP SK59Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810111223492), received between Jul 25, 2025 and Mar 2, 2026 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 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 EXCESS BONE GROWTH CAUSING DISCOMFORT. 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: Discomfort

  MAUDE report 24485505 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN ADDUCTOPLASTY AT THE 2ND AND 3RD TARSOMETATARSAL (TMT) JOINTS, A LAPIPLASTY AT THE 1ST TMT, AND METATARSOPHALANGEAL (MTP) JOINT FUSION. AFTER THE INITIAL SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED FROM THE MTP JOINT ON (B)(6) 2026 DUE TO WOUND DEHISCENCE AND AN EXPOSED PLATE AT THE MTP INCISION SITE. ALL OTHER INCISION SITES WERE HEALED AND THE MTP JOINT WAS FUSED. 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: Wound Dehiscence

  MAUDE report 24284246 ↗
• InjuryJul 25, 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 ON (B)(6) 2025 DUE TO WOUND DEHISCENCE. THE WOUND WAS SUTURED CLOSED ONCE THE HARDWARE WAS REMOVED. 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: Wound Dehiscence

  MAUDE report 22611032 ↗