NA 422.395Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982215895), received between Dec 15, 2017 and Aug 5, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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. 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 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 OR IF 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 65. THIS REPORT IS 3 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281106 ↗
• 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 65. THIS REPORT IS 4 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12281101 ↗
• 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 7324203 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF A TITANIUM DISTAL FEMUR LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE AND THIRTEEN (13) SCREWS TO AN UNKNOWN ZIMMER PLATE CONSTRUCT DUE TO A FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE ON (B)(6) 2017. ONE (1) LISS PLATE ALONG WITH APPROXIMATELY THIRTEEN (13) UNKNOWN SCREWS WERE INITIALLY IMPLANTED ON AN UNKNOWN DATE A FEW YEARS AGO. BASED ON A PREVIOUSLY TAKEN X-RAY (UNAVAILABLE) TAKEN BEFORE THE REVISION SURGERY, THE PLATE AND SCREWS ALL SEEMED INTACT AND WERE FOUND INTACT DURING SURGERY. THE REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN DELAY IN SURGERY DUE TO THREE (3) SYNTHES SCREWDRIVERS BREAKING WHILE REMOVING THE THREE (3) COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. AFTER THE SCREWDRIVERS BROKE, THE SCREWS HAD TO BE CUT OUT WITH A BIG BURR. IT IS UNKNOWN IF THERE WERE ANY FRAGMENTS LEFT INSIDE THE PATIENT. THIS REPORT ADDRESSES THE POSTOPERATIVE REVISION DUE TO PATIENT¿S FRACTURE WHICH WAS SLIGHTLY DISTAL TO THE SYNTHES LISS FEMUR PLATE THE INTRAOPERATIVE ISSUE OF COLD WELDED / CROSS THREADED SCREWS THAT WERE STUCK TO THE PLATE. THE INTRAOPERATIVE ISSUE OF TH

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 7121389 ↗