Control 360 SK12Recalls & reported problems

Summary

The FDA's MAUDE database contains 195 adverse event reports that list this exact device (DI 00853114006006), received between Apr 20, 2017 and Apr 21, 2024 — classified as 115 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Break” (102 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 195 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 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) 2022, ALL HARDWARE WAS REMOVED 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: Insufficient Information

  MAUDE report 19150097 ↗
• InjuryApr 9, 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) 2021, ALL HARDWARE WAS REMOVED ON 03-13-2024 DUE TO PAIN WHEN WEARING SHOES. 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 19076811 ↗
• InjuryApr 4, 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) 2021, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAIN WHEN WEARING SHOES. 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 19043425 ↗
• InjuryMar 30, 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 HARDWARE IRRITATION WHEN WEARING SHOES. 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: Skin Inflammation/ Irritation

  MAUDE report 19009021 ↗
• InjuryMar 20, 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, ALL HARDWARE WAS REMOVED ON (B)(6)2024 DUE TO 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

  MAUDE report 18946931 ↗
• InjuryMar 12, 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO PAIN AND IRRITATION. 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 18891605 ↗
• InjuryFeb 29, 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 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 18813514 ↗
• InjuryFeb 27, 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, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO INFECTION FROM AN UNKNOWN CAUSE. 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: Post Operative Wound Infection

  MAUDE report 18794345 ↗
• InjuryFeb 22, 2024Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2024 DUE TO NONUNION AND POOR CORRECTION. ADDITIONAL INFORMATION INDICATES ONE SCREW BROKE WHILE BEING REMOVED AND A PORTION OF THE SCREW WAS RETAINED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18764453 ↗
• InjuryJan 19, 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 INFECTION. 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: Post Operative Wound Infection

  MAUDE report 18548448 ↗
• 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, ALL HARDWARE WAS REMOVED ON (B)(6)2023 DUE TO PAIN AND 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; Pain

  MAUDE report 18439913 ↗
• 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, ALL HARDWARE WAS REMOVED ON (B)(6)2023 DUE TO DISCOMFORT. A SOFT TISSUE MASS LOCATED NEXT TO THE DORSAL PLATE WAS ALSO REMOVED. 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

  MAUDE report 18438273 ↗
• InjuryDec 27, 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) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO PAIN AND SOFT TISSUE IRRITATION. 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; Skin Inflammation/ Irritation

  MAUDE report 18407360 ↗
• InjuryDec 7, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6)2023 DUE TO SCREW BREAKAGE, NON-UNION AND BUNION RECURRENCE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18288992 ↗
• InjuryDec 5, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON 11-08-2023 DUE TO BROKEN SCREWS AND PAINFUL HARDWARE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 18271883 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF A THREADED OLIVE WIRE BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. A BACK-UP DEVICE WAS AVAILABLE TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO REPORT OF DELAY, NOR IMPACT OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18271882 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, A BROKEN MEDIAL PLATE WAS DISCOVERED DURING A POST-SURGERY FOLLOW-UP. 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 18271881 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON 10-27-2023 DUE TO 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

  MAUDE report 18196380 ↗
• InjuryNov 21, 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 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 18185484 ↗
• InjuryNov 3, 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 NON-UNION AND BROKEN HARDWARE. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18069633 ↗
• InjuryOct 6, 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) 2023 ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO HARDWARE 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 17886650 ↗
• InjurySep 19, 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) 2023 ALL HARDWARE WAS REMOVED ON (B)(6) 2023 DUE TO PAIN RELATED TO PROMINANCE OF THE PLATE. 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 17774329 ↗
• MalfunctionAug 1, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, RADIOGRAPHIC IMAGING INDICATES THE PATIENT HAS A LOOSE PLATE. ALL HARDWARE CURRENTLY REMAINS IMPLANTED WITH NO REPORTED PLANS TO REMOVE/REVISE THE HARDWARE. 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, AN MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438740 ↗
• InjuryJul 27, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2022, THE DORSAL PLATE WAS REMOVED FROM IN A REVISION SURGERY 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 17410045 ↗
• MalfunctionJul 19, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF AN OLIVE WIRE DRILL BROKE OFF AND WAS RETAINED IN THE PATIENT'S BONE DURING A BUNION PROCEDURE ON (B)(6) 2023. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS UNLIKELY TO RESULT IN A SERIOUS INJURY IF IT RECURRED, THE COMPANY HAS DECIDED TO FILE THE MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17352016 ↗