NA 422.349Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982215819), received between Jun 22, 2017 and Jun 28, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2017Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED FOR AN INFECTED NON-UNION OF THE LEFT METAPHYSEAL-DIAPHYSEAL AREA OF A DISTAL FEMUR ON (B)(6) 2017. THE DATE OF THE ORIGINAL PROCEDURE WAS FIVE MONTHS AGO IN (B)(6) 2017, AT WHICH TIME THE PATIENT SUFFERED POLYTRAUMA. SUBSEQUENTLY, IT IS UNKNOWN WHEN THE INFECTED NON-UNION WAS IDENTIFIED AND THERE IS NO INFORMATION REGARDING PATIENT SYMPTOMS. REMOVED HARDWARE INCLUDED: ONE (1) LESS INVASIVE STABILIZATION SYSTEM (LISS) DISTAL FEMUR PLATE (INTACT) AND ELEVEN (11) 5.0MM TITANIUM LOCKING SCREWS OF VARIOUS SIZES. IT WAS REPORTED THAT THE SURGICAL TEAM HAD TO DRILL THE HEAD OUT OF SOME (EXACT QUANTITY UNKNOWN) OF THE 5.0MM LOCKING SCREWS DUE TO THE SCREW HEADS GETTING COLD-WELDED TO THE PLATE. NOTHING UNEXPECTEDLY OCCURRED DURING THE REMOVAL PROCEDURE. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. REVISION SURGERY DUE TO MAL-UNION/INFECTION IS ADDRESSED IN (B)(4). THIS REPORT ADDRESSES THE INTRAOPERATIVE ISSUE WITH THE LOCKING SCREWS. THIS REPORT IS FOR ONE (1) DISTAL FEMUR LISS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6673098 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED FOR AN INFECTED NON-UNION OF THE LEFT METAPHYSEAL-DIAPHYSEAL AREA OF A DISTAL FEMUR ON (B)(6) 2017. THE DATE OF THE ORIGINAL PROCEDURE WAS FIVE MONTHS AGO, IN (B)(6) 2017, AT WHICH TIME THE PATIENT SUFFERED POLYTRAUMA. SUBSEQUENTLY, IT IS UNKNOWN WHEN THE INFECTED NON-UNION WAS IDENTIFIED AND THERE IS NO INFORMATION REGARDING PATIENT SYMPTOMS. REMOVED HARDWARE INCLUDED: ONE (1) LESS INVASIVE STABILIZATION SYSTEM (LISS) DISTAL FEMUR PLATE (INTACT) AND ELEVEN (11) 5.0 MM TITANIUM LOCKING SCREW OF VARIOUS SIZES. IT WAS REPORTED THAT THE SURGICAL TEAM HAD TO DRILL THE HEAD OUT OF SOME (EXACT QUANTITY UNKNOWN) OF THE 5.0 MM LOCKING SCREWS DUE TO THE SCREW HEADS GETTING COLD-WELDING TO THE PLATE WHICH IS TO BE EXPECTED WITH THIS TYPE OF PLATE. NOTHING UNTOWARD OCCURRED DURING THE REMOVAL PROCEDURE. THERE WERE NO UNANTICIPATED SURGICAL DELAYS, NO DEVICE FRAGMENTS, NO ADDITIONAL X-RAYS OR ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE INFECTED SITE WAS PACKED WITH ANTIBIOTIC BEADS AND A WOUND VACUUM WAS PLACED. AN EXTERNAL FIXATOR WAS PLACED FOR THE NON-UNION FOR THE DISTAL FEMUR. THERE IS NO INFORMATION REGARDING A FUTURE DATE OF RETURN

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 6661574 ↗