SpeedMTP Compression Screws SK60Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810111223515), received between May 1, 2025 and Mar 2, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (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.

• 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 24486135 ↗
• 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 24284307 ↗
• InjuryNov 4, 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 AT THE MTP JOINT WAS REMOVED ON (B)(6) 2025 DUE TO DEHISCENCE AND A NON-HEALING WOUND AT THE DORSAL ASPECT OF THE HALLUX. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 23464619 ↗
• 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 22612041 ↗
• InjuryJun 1, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, RADIOGRAPHIC IMAGES FROM A POST-OP FOLLOW-UP SHOW LUCENCY AT THE JOINT AND A BROKEN SCREW. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE CURRENTLY REMAINS IMPLANTED, WITH NO SCHEDULED PLANS TO REVISE OR REMOVE THE HARDWARE REPORTED AT THIS TIME. ALTHOUGH THERE HAS BEEN NO INJURY REPORTED AND THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, A MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22120813 ↗
• InjuryMay 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 21947305 ↗