NA 206.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982147233), received between Jan 2, 2020 and Nov 19, 2024 — classified as 7 injuries.

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 7 most recent of 7 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 20722627 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 5 OF 12 FOR PC-(B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON 5/1/2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/16 DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14147863 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 12 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2021, THE PATIENT UNDERWENT A DEVICE REMOVAL ON (B)(6) 2022 IN THE RIGHT ANKLE DUE TO PAIN. IT WAS REPORTED THAT ALL IMPLANTS WERE REMOVED SUCCESSFULLY AND WITHOUT COMPLICATION. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/16 DEVICE. THIS COMPLAINT INVOLVES 12 DEVICES.

  Patient problems: Pain

  MAUDE report 14147856 ↗
• 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) 4.0 CANCELLOUS BONE SCREW FULLY THRD/16. THIS IS REPORT 11 OF 11 FOR (B)(4).

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

  MAUDE report 12489479 ↗
• 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/16MM. THIS IS REPORT 6 OF 11 FOR (B)(4).

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

  MAUDE report 12489257 ↗
• 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 6 OF 8 FOR REPORT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9705748 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY REVISION TO ADDRESS LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. IT WAS NOTED THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016. DURING THE PROCEDURE, IT WAS IDENTIFIED THAT TWO (2) SYNTHES SCREWS WERE USED ALONG THE LATERAL SIDE TO ACT AS REBARB FOR CEMENT, UPON RELEASING THE TOURNIQUET, A LARGE RUSH OF BLOOD WAS OBSERVED FROM THE POSTERIOR KNEE. THE BLEEDING WAS CONTROLLED AND THE PATIENT WAS IN STABLE CONDITION WITH NO APPARENT COMPLICATIONS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 9538503 ↗