NA 422.396Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982215901), received between Mar 8, 2018 and Aug 5, 2021 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 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 75. THIS REPORT IS 7 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281117 ↗
• 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 75. THIS REPORT IS 5 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281113 ↗
• 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 75. THIS REPORT IS 6 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281105 ↗
• MalfunctionMar 8, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THERE WERE MULTIPLE MISSING SCREWS IN AN EVALUATIONS SET. SET WAS NEVER USED OR STERILIZED. TRAYS NEVER ENTERED OPERATING ROOM SUITE. MISSING SCREWS IN TRAYS WERE DISCOVERED WHEN TOTE WAS OPENED TO CHECK CONDITION OF TRAYS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324242 ↗