NA 55-28922Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540356444), received between May 22, 2019 and May 28, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K014263, K221855, K240651); they may or may not involve this specific model.

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.

• MalfunctionMay 28, 2026Fracture

  IT WAS REPORTED THAT THE RECONSTRUCTION PLATE BROKE 6 MONTH AFTER SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 25313719 ↗
• InjuryMay 22, 2019Break

  IT WAS REPORTED BY A SURGEON THAT DURING A POST-SURGICAL APPOINTMENT IT WAS FOUND AN IMPLANT PLATE HAD BROKEN POST-OPERATIVELY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE SUCH AS WHAT HAPPENED WITH THE ORIGINAL PROCEDURE, HOW THE PLATE BROKE, OR IF A REVISION SURGERY IS PLANNED, BUT EVENTUAL MEDICAL INTERVENTION IS ASSUMED.

  Patient problems: No Code Available

  MAUDE report 8632455 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014263, K221855, K240651. One submission often covers many models, so check the product and lot details in each record.

• Z-0610-2009 · Sep 19, 2008 · Terminated
  Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911. A mandib