Lapiplasty® 4.0mm Fully Threaded Screw SK38Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00853114006303), received between Aug 18, 2023 and Jun 11, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE 4.0 THREADED SCREW WAS REMOVED ON (B)(6) 2026 DUE TO HARDWARE IRRITATION AND DISCOMFORT. 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: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 25473173 ↗
• InjuryAug 20, 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 ON (B)(6) 2025 DUE TO NONUNION. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22849613 ↗
• MalfunctionJun 19, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, 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 22289244 ↗
• InjuryJun 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) 2024, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO AN ADVERSE REACTION TO THE HARDWARE, RESULTING IN PROLONGED INFLAMMATION AROUND THE SURGICAL SITE AND CYST FORMATION. 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: Cyst(s); Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 22216723 ↗
• InjuryMar 18, 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)2024, AN SK38 SCREW WAS REMOVED IN OFFICE ON (B)(6)2025 DUE TO PATIENT COMPLAINTS OF PAIN, SWELLING AND A BUMP ON THE SIDE OF THEIR FOOT. UPON X-RAY REVIEW, IT WAS DISCOVERED A SCREW WAS BACKING OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21638820 ↗
• InjuryNov 26, 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, A FULLY THREADED SCREW WAS REMOVED ON (B)(6) 2024 DUE TO BACKING OUT AND TENTING THE SKIN. 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 20779855 ↗
• InjurySep 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) 2024, ALL HARDWARE WAS REMOVED AND REVISED ON (B)(6) 2024 DUE TO 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243077 ↗
• MalfunctionJul 9, 2024Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, 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 19706067 ↗
• InjuryJan 3, 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) 2023 DUE TO PAIN AT THE IMPLANT SITE. 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 18438276 ↗
• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT A FULLY THREADED SCREW BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. THERE WAS NO REPORT OF DELAY, NOR IMPACT OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT. ALTHOUGH THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE IN THIS EVENT, 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: Device Embedded In Tissue or Plaque

  MAUDE report 18416286 ↗
• MalfunctionDec 7, 2023Break; Break

  IT WAS REPORTED THAT A FULLY THREADED SCREW BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. THERE WAS NO REPORT OF DELAY, NOR IMPACT OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT. ALTHOUGH THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE IN THIS EVENT, 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: Device Embedded In Tissue or Plaque

  MAUDE report 18288994 ↗
• InjuryAug 18, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY (B)(6) 2023, A BROKEN SCREW WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2023. THE TIP OF THE BROKEN SCREW WAS RETAINED IN THE PATIENT'S BONE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17577320 ↗