Lapiplasty SK26Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00853114006198), received between Jun 4, 2021 and Jun 11, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 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) 2024, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NON-UNION WITH BUNION RECURRENCE. 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

  MAUDE report 22191432 ↗
• InjuryApr 30, 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 DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A BROKEN TOE AND THE PATIENT BEING UNSATISFIED WITH THE ORIGINAL CORRECTION. 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 21940376 ↗
• InjuryOct 17, 2024Adverse 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO DISCOMFORT PRIMARILY DUE TO THE OVERALL FEELING OF THE HARDWARE, AND A BROKEN SCREW THAT WAS DISCOVERED VIA RADIOGRAPHIC IMAGE FROM A POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 20477617 ↗
• InjuryJul 2, 2024Adverse 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO NON-UNION AND LOSS OF CORRECTION. 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19662780 ↗
• InjuryApr 15, 2024Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO NON-UNION AND A BROKEN SCREW THAT WAS RETAINED IN THE PATIENT'S BONE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19112816 ↗
• InjuryDec 28, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO 2 BROKEN SCREWS THAT WERE DISCOVERED VIA RADIOGRAPHIC IMAGING. ADDITIONAL INFORMATION INDICATES THE PATIENT HAD PAIN IN THE ARCH OF THE FOOT, NERVE PAIN ALONG THE INCISION SITE, AND A NONUNION. THE SITE WAS REVISED WITH NON-TMC HARDWARE. HOWEVER, THE TIPS OF THE BROKEN SCREWS WERE RETAINED IN THE PATIENT'S BONE AS THEY COULD NOT BE REMOVED BY THE SURGEON. NO OTHER PATIENT OUTCOMES WERE REPORTED.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18416182 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6)2023 DUE TO PAIN. 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 18341474 ↗
• InjuryNov 16, 2023Adverse 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) 2022, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 18148698 ↗
• InjuryMar 26, 2023Adverse 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) 2022, A COMPRESSION SCREW WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023 DUE TO PAIN. UPON REMOVAL, 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 16616992 ↗
• InjuryJan 5, 2023Adverse 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) 2022, TWO SCREWS WERE REMOVED IN A REVISION SURGERY ON (B)(6) 2022 DUE TO NONUNION. 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: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16110324 ↗
• InjuryFeb 17, 2022Loosening 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) 2021, 8 SCREWS, 2 PLATES, AND 2 COMPRESSION SCREWS WERE REMOVED ON (B)(6) 2021 DUE TO PAIN AND BOTH COMPRESSION SCREWS BEING LOOSE. AFTER THE REMOVAL, THE PATIENT INDICATES THE PAIN "IS MOSTLY GONE". THERE WAS NO OTHER REPORT OF ANY PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 13552760 ↗
• InjuryJun 4, 2021Migration; Migration

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2020, THE PATIENT BEGAN HAVING PAIN AT THE SURGICAL SITE. DURING A FOLLOW-UP VISIT ON (B)(6) 2021, IT WAS CONFIRMED VIA RADIOGRAPHIC IMAGING THAT A COMPRESSION SCREW WAS BACKING OUT. ADDITIONAL INFORMATION RECEIVED INDICATES THE SCREW WAS REMOVED ON (B)(6) 2021 AND THE PATIENT REPORTED AN IMPROVEMENT. THERE WAS NO OTHER REPORT OF ANY PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 11942136 ↗