NA 78-92003Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · FACIAL ID-ORTHOG-3PLATES · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327370775), received between Feb 24, 2022 and May 7, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Inadequacy of Device Shape and/or Size3
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information3
- Itching Sensation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Device Appears to Trigger Rejection; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF ITCHINESS IN THE AREA OF THE LE FORT I OSTEOTOMY. X-RAYS SHOWED 2¿3 LOOSE SCREWS, AND THE HARDWARE WILL BE REMOVED.
Patient problems: Itching Sensation
MAUDE report 25110952 ↗MalfunctionApr 30, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PLATE WASN'T FLUSH WITH THE BONE AND THE SURGEON HAD TO USE STOCK PLATES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25043171 ↗MalfunctionSep 12, 2025Fracture; Fracture
InjuryJul 30, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22665862 ↗InjuryOct 15, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem
INCONSISTENCY BETWEEN GUIDES AND MANUFACTURED PLATE HAS LED TO DIFFICULTIES WHILE PLATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20451441 ↗MalfunctionJul 14, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT IT WAS NOTICED DURING THE PROCEDURE THE PLATES DID NOT IT AS EXPECTED. THE PLATES WERE NOT ABLE TO BE MODIFIED AND WERE NOT USED TO COMPLETE THE SURGERY. THERE WERE BACKUP PLATES AVAILABLE TO SUCCESSFULLY COMPLETE THE SURGERY, THERE WAS NO SIGNIFICANT SURGERY DELAY AND NO ADVERSE EVENTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325412 ↗InjuryFeb 24, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PLATE WAS BROKEN. THE PATIENT NEEDED TO HAVE THE PLATE REMOVED. THERE WAS NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13595190 ↗
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.