TMC SpeedMTP SK58Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810111223508), received between Apr 1, 2025 and Apr 21, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE PATIENT EXPERIENCED A FRACTURE. 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 24941551 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN TAPPING DOWN THE PLATE DURING AN INITIAL BUNION SURGERY ON (B)(6) 2026, A FRACTURE OCCURRED AT THE MEDIAL ASPECT OF THE METATARSAL & LATERAL ASPECT OF THE PHALANX. 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: Bone Fracture(s)

  MAUDE report 24903723 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO A DISTAL FRACTURE. ADDITIONAL INFORMATION INDICATES THE PATIENT HAD POOR BONE QUALITY. 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: Bone Fracture(s)

  MAUDE report 24852052 ↗
• MalfunctionMar 31, 2026

  WHILE IN OPERATION ROOM, SURGEON WAS DRILLING, PULLED OUT DRILL BUT TIP OF DRILL BIT (1.6MM) WAS STILL IN FOOT. FLAT PLATE TAKEN, RADIOLOGIT TO READ PRIOR TO CLOSURE, SURGEON UNABLE TO REMOVE TIP OF DRILL BIT; TIP LEFT IN PLACE, WOUND IRRIGATED AND CLOSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24741272 ↗
• InjuryMay 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) 2025, THE PLATE WAS REMOVED ON (B)(6) 2025 DUE TO THE WOUND NOT CLOSING. THE WOUND WAS OPEN AT THE BRIDGE OF THE PLATE, EXPOSING THE PLATE. 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: Impaired Healing

  MAUDE report 22093221 ↗
• InjuryApr 1, 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, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO THE PLATE LIFTING OUT OF THE BONE. AN X-RAY DETECTED THAT THE PLATE WAS PLACED TOO PROXIMAL AND THIS ONLY ALLOWED ONE POINT OF FIXATION OF THE DISTAL END. IN ADDITION, A SCREW APPEARED TO FRACTURE THROUGH THE BASE OF THE PROXIMAL PHALANX ADDING TO THE OVER ALL INSTABILITY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21749227 ↗