NA 206.050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982147363), received between Nov 9, 2021 and Jul 27, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SCREW INSERTION HEAD BROKE OFF, NOTED GOOD BONE QUALITY. FRAGMENTS GENERATED WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/50. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112221 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REMOVAL SURGERY OF PROXIMAL TIBIA HARDWARE DUE TO PAIN. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1)4.0 CANCELLOUS BONE SCREW FULLY THRD/50. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12778771 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REMOVAL SURGERY OF PROXIMAL TIBIA HARDWARE DUE TO PAIN. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 4.0 CANCELLOUS BONE SCREW FULLY THRD/50. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12778757 ↗