NA 206.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982147240), received between Dec 12, 2017 and Nov 19, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Corroded; Corroded

  IT WAS REPORTED THAT ON (B)(6) 2024 A REVISION OCCURRED DUE TO PAIN. THE PATIENT'S ORIGINAL SURGERY WAS A RIGHT ULNA ORIF ON (B)(6) 2021. DURING THE REMOVAL IT WAS DISCOVERED MULTIPLE SCREWS WERE RUSTED. SCREWS WERE REMOVED. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20722613 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT EXPERIENCED AN ALLERGIC REACTION CAUSED BY AN IMPLANT IN THE ANKLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/18MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15914031 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT EXPERIENCED AN ALLERGIC REACTION CAUSED BY AN IMPLANT IN THE ANKLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/18MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15914023 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT EXPERIENCED AN ALLERGIC REACTION CAUSED BY AN IMPLANT IN THE ANKLE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/18MM. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15913996 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT REPORTED BLISTERS ON SURGICAL FOOT, WHICH HAS SPREAD TO OTHER PARTS OF HER BODY. PATIENT IS BEING TESTED FOR AN ALLERGIC REACTION TO THE IMPLANTS. NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1)4.0 CANCELLOUS BONE SCREW FULLY THRD/18. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 15183776 ↗
• MalfunctionDec 17, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, AN ORDER HAD A RIPPED ON THE SIDE FROM THE ACTUAL RIP OPENING WHEN IT ARRIVED FROM COLORADO AND IT WAS EMPTY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/18. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026690 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE HARDWARE IN QUESTION WAS REMOVED DUE TO INFECTION. IT IS UNKNOWN WHEN THE HARDWARE WAS ORIGINALLY IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/18MM. THIS IS REPORT 2 OF 11 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12488625 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 8 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705769 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE THERE WAS A HARDWARE REMOVAL OF THE ONE THIRD TUBULAR PLATE WITH 7 HOLES AND UNKNOWN SCREWS DUE TO INFECTION. THE TUBULAR PLATE AND UNKNOWN SCREWS WERE IMPLANTED ON AN UNKNOWN DATE. AFTER THE PROCEDURE, THERE WAS A PRESENCE OF INFECTION. PROCEDURE WAS SUCCESSFULLY COMPLETED AND ALL HARDWARE WERE REMOVED. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS 7 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705761 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HARDWARE REMOVAL SURGERY ON (B)(6, 2017 DUE TO A REFRACTURED ANKLE. THE PATIENT ORIGINALLY UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ANKLE AND WAS IMPLANTED WITH A CANCELLOUS BONE SCREW, 3 CORTEX SCREWS, AND A TUBULAR PLATE ON AN UNKNOWN DATE IN (B)(6) 2017. HOWEVER, SOMETIME LAST WEEK, THE PATIENT TRIPPED ON A CURB AND REFRACTURED HIS LEFT ANKLE. THE RESULTS OF THE HARDWARE REMOVAL SURGERY WERE SUCCESSFUL, THE PATIENT WAS REPORTED TO BE IN EXCELLENT CONDITION. ALL THE ORIGINALLY IMPLANTED HARDWARE WAS REPLACED WITH NEW IMPLANTS. THERE WAS NO REPORTED SURGICAL DELAY. ALL AVAILABLE INFORMATION WAS RECEIVED FROM THE SALES CONSULTANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7108589 ↗