NA 422.393Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982215871), received between Jul 21, 2021 and Aug 5, 2021 — classified as 3 injuries.

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

• InjuryAug 5, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE ORTHOPEDIC PLATE AND SCREWS BACK OUT OR WERE BROKEN/FAILED. THE PATIENT WAS REVIVED WITH ANOTHER PLATE. THE INITIAL ORIF OCCURRED ON (B)(6) 2021. IT WAS DISCOVERED ON (B)(6) 2021, THAT THE HARDWARE HAD DETACHED FROM THE PATIENT'S FEMUR. NO BROKEN FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS RECOVERING SUCCESSFULLY. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LOCKING SCREW SELF-DRILLING 40. THIS REPORT IS 2 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281089 ↗
• InjuryAug 5, 2021Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE ORTHOPEDIC PLATE AND SCREWS BACK OUT OR WERE BROKEN/FAILED. THE PATIENT WAS REVIVED WITH ANOTHER PLATE. THE INITIAL ORIF OCCURRED ON (B)(6) 2021. IT WAS DISCOVERED ON (B)(6) 2021, THAT THE HARDWARE HAD DETACHED FROM THE PATIENT'S FEMUR. NO BROKEN FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS RECOVERING SUCCESSFULLY. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LOCKING SCREW SELF-DRILLING 40. THIS REPORT IS 1 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281088 ↗
• InjuryJul 21, 2021Break; Migration; Break; Migration

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE SCREWS EITHER BACKED OUT OR WERE BROKEN. THE PATIENT WAS REVISED WITH ANOTHER PLATE. PROCEDURE WAS WITH AN UNKNOWN DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 5.0MM TITANIUM (TI) LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 12205132 ↗