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NA 55-15920Recalls & reported problems

Stryker Leibinger GmbH & Co. KG · PRIMARY HEMI MAND PLATE,RIGHT,W.TEMPLATE · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540356390), received between Jul 11, 2019 and Dec 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture2

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1

Recent adverse event reports

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

  • InjuryDec 14, 2021Fracture; Fracture

    IT WAS REPORTED THAT A PLATE THAT WAS PLACED FOR RECONSTRUCTION OF A RIGHT MANDIBULAR TUMOR BROKE. THERE WAS REVISION SURGERY TO REPLACE THE PLATE.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13003835 ↗
  • InjuryJul 11, 2019Fracture

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SPONTANEOUS FRACTURE OF THE MANDIBULAR RECONSTRUCTION PLATE WITHOUT ANY NOTION OF MANDIBULAR TRAUMA OR SHOCK. THE PLATE WAS INITIALLY IMPLANTED ON (B)(6) 2017. THE PATIENT UNDERWENT AN ADDITIONAL EXAMINATION, AND A REVISION SURGERY WAS PERFORMED. A NEW PLATE WAS IMPLANTED.

    Patient problems: No Code Available

    MAUDE report 8779408 ↗

Other PLATE, BONE devices

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Sources and updates

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