Lapiplasty SpeedPlate SK53Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00810111222396), received between Nov 27, 2024 and Aug 3, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Break

  It was reported that after an initial bunion surgery on (b)(6) 2025, all hardware was removed on (b)(6) 2026 due to non-union and a broken staple. No other patient outcomes were reported as a result of this event.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 50113432 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE DORSAL PLATE WAS REMOVED ON (B)(6) 2026 DUE TO EHL IRRITATION. THE SURGEON ATTEMPTED TO REMOVE THE MEDIAL PLATE BUT ELECTED TO LEAVE IT IN DUE TO OPERATIVE TIME CONSTRAINTS. 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: Skin Inflammation/ Irritation

  MAUDE report 25322847 ↗
• InjuryMay 20, 2026Break

  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) 2026 DUE TO NONUNION AND BROKEN PLATE TINES. TWO TINES (INNER PROXIMAL AND INNER DISTAL) ON THE DORSAL QUAD PLATE WERE BROKEN. THE SURGEON REMOVED THE INNER PROXIMAL TINE, BUT THE INNER DISTAL TINE REMAINS IMPLANTED AS THE SURGEON WAS UNABLE TO REMOVE IT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 25236750 ↗
• InjuryMar 31, 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 RECENT REVISION SURGERY DUE TO PAIN, SWELLING, LOOSENED AND BROKEN HARDWARE. THE REVISION SURGERY WAS APPROXIMATELY THREE WEEKS PRIOR TO (B)(6) 2026, HOWEVER THE EXACT DATE IS UNKNOWN. THE HARDWARE HAD LOOSENED AND A BROKEN SCREW WAS DISCOVERED VIA RADIOGRAPHIC IMAGE DURING A POST-OP FOLLOW-UP. THE PATIENT REPORTED THAT SHE SUBSEQUENTLY DEVELOPED HAMMER TOES OF THE 2ND, 3RD, AND 4TH TOES, AND EXPERIENCED PAIN WHEN PUTTING ON SHOES AND IF ON THE FOOT FOR MORE THAN AN HOUR. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24743419 ↗
• InjuryDec 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, HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO PAIN. IT WAS NOTED THAT A SPEEDPLATE HAD WORKED ITSELF OUT MEDIALLY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 23921175 ↗
• InjuryOct 15, 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 ON (B)(6) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO LOSS OF CORRECTION AND THE MEDIAL IMPLANT BEING DISPLACED. THE PATIENT WAS NON-COMPLIANT, FELL DOWN, AND INJURED HER FOOT. UPON REMOVAL OF THE HARDWARE, IT WAS CONFIRMED THE MEDIAL CUNEIFORM WAS FRACTURED. 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 23304697 ↗
• InjuryAug 14, 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, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO AN ELEVATED FIRST METATARSAL. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED WITH ANY TMC DEVICE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Malunion of Bone

  MAUDE report 22804509 ↗
• InjuryMay 30, 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 ON (B)(6) 2025, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 AFTER THE PATIENT EXPERIENCED A FALL CAUSING THE DORSAL PLATE TO BACK OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111815 ↗
• 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 21940375 ↗
• MalfunctionDec 1, 2024Loosening 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) 2024, TWO BACKED OUT SPEEDPLATES WERE DISCOVERED VIA A RADIOGRAPHIC IMAGE FROM A POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. 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: Cellulitis

  MAUDE report 20815525 ↗
• InjuryNov 27, 2024Loosening 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) 2024, THE DORSAL AND MEDIAL SPEEDPLATE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2024 DUE TO THE MEDIAL SPEEDPLATE BACKING OUT. THE CORRECTION WAS NOT HELD AND THE PATIENT WAS NOT FUSED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792920 ↗