NA 422.348Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982215802), received between Dec 15, 2017 and Oct 4, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM DISTAL FEMUR PLATE AND ELEVEN (11) UNKNOWN SCREWS DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. ALL DEVICES WERE SUCCESSFULLY REMOVED. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWELVE (12) DEVICES. THIS REPORT IS FOR ONE (1) TI DISTAL FEMUR LISS PLATE 13 HOLES/316MM-RIGHT. THIS IS REPORT 1 OF 12 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9156104 ↗
• 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 7121194 ↗