Nanoplasty System SK57Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00810111222464), received between Jul 4, 2024 and Sep 22, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jun 2, 2024Open, Classified

   Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.

   Z-2718-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50856501 ↗
• MalfunctionJun 18, 2026Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, A BROKEN PLATE WAS DISCOVERED VIA RADIOGRAPHIC IMAGING. LOSS OF REDUCTION/CORRECTION FROM THE INITIAL SURGERY WAS ALSO NOTED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE REMAINS IMPLANTED. ALTHOUGH THERE HAS BEEN NO INJURY REPORTED AND NO INFORMATION HAS BEEN RECEIVED INDICATING THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY TO DATE, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, AN MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25550142 ↗
• InjuryFeb 17, 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 REVISION SURGERY ON (B)(6) 2026 DUE TO PAIN AND PLANTARFLEXED CAPITAL FRAGMENT. 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: Pain

  MAUDE report 24367485 ↗
• InjuryFeb 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE SURGICAL SITE WAS REVISED ON (B)(6) 2026 DUE TO PAIN AND PLANTAR FLEXION/TRANSLATION OF THE CAPITAL FRAGMENT. IT WAS ALSO NOTED THAT THE 10MM SCREW MAY HAVE BACKED OUT SLIGHTLY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 24277559 ↗
• InjuryJan 16, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, TWO SCREWS WERE REMOVED ON (B)(6) 2025 DUE TO A SCREW THAT BACKED OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096038 ↗
• InjuryDec 19, 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 SURGERY ON (B)(6) 2025 DUE TO A DISPLACED CAPITAL FRAGMENT AFTER THE PATIENT TRIPPED AND FELL. 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 23855790 ↗
• InjuryDec 18, 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 ON (B)(6) 2025 DUE TO THE PATIENT FEELING THE PLATE. THE SURGEON NOTED THE PLATE WAS SITTING DORSALLY. 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 23839444 ↗
• InjurySep 8, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2025 DUE TO PAIN AND TWO BROKEN SCREWS. THE TWO BROKEN SCREWS WERE DISCOVERED VIA RADIOGRAPHIC IMAGE DURING A POST-OPERATIVE FOLLOW-UP ON (B)(6) 2025. THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. THE DISTAL TIPS OF BOTH BROKEN SCREWS WERE RETAINED AS THE SURGEON WAS UNABLE TO REMOVE THEM. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 22994933 ↗
• InjuryJul 16, 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 SWELLING AND POTENTIAL POST-OP ACQUIRED INFECTION. 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: Swelling/ Edema; Unspecified Infection

  MAUDE report 22522066 ↗
• InjuryJul 5, 2025Break; Break

  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 PAIN, LOSS OF CORRECTION AND A BROKEN SCREW THAT WAS DISCOVERED VIA A RADIOGRAPHIC IMAGE FROM A 3-WEEK POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 22406886 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, A BROKEN SCREW WAS DISCOVERED VIA RADIOGRAPHIC IMAGE FROM A POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE CURRENTLY REMAINS IMPLANTED. 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 22328311 ↗
• InjuryJun 24, 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 PATIENT EXPERIENCED LOSS OF CORRECTION AND A BONE FRACTURE. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED WITH ANY TMC DEVICE. ALL HARDWARE CURRENTLY REMAINS IMPLANTED, WITH NO SCHEDULED PLANS TO REVISE OR REMOVE THE HARDWARE REPORTED AT THIS TIME. UPON RECEIPT OF ANY ADDITIONAL INFORMATION, THE FILE WILL BE UPDATED AND REASSESSED AS NEEDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22325036 ↗
• InjuryJun 12, 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 PAIN AND IRRITATION ON THE MEDIAL SIDE OF THE FOOT. 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: Pain; Skin Inflammation/ Irritation

  MAUDE report 22193695 ↗
• InjuryApr 21, 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 AFTER THE PATIENT FELL STEPPING OFF OF A CURB AND THE METATARSAL HEAD PULLED THROUGH SCREW FIXATION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876946 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE PATIENT'S MEDIAL CORTEX OF THE FIRST METATARSAL WAS FRACTURED DURING DRILLING FOR IMPLANTATION OF A DISTAL/DORSAL LOCKING SCREW. 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 21610787 ↗
• InjuryMar 5, 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 IN A REVISION SURGERY ON (B)(6) 2025 DUE TO THE METATARSAL HEAD BEING PLANTAR FLEXED MORE THAN DESIRABLE FROM IMPROPER PLACEMENT OF THE PLATE DURING IMPLANTATION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532651 ↗
• InjuryFeb 10, 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, RADIOGRAPHIC IMAGES FROM A POST OPERATIVE FOLLOW-UP ON (B)(6) 2025 INDICATE THE PATIENT IS EXPERIENCING LOSS OF CORRECTION AND A POTENTIAL FRACTURE THROUGH THE MEDIAL CORTEX. 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 21351274 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, APPROXIMATELY TWO WEEKS AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, THE PATIENT'S METATARSAL FRACTURED IN THE LATERAL ASPECT OF THE PROXIMAL SHAFT. 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 19675360 ↗