NA 78-92006Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · FACIAL ID-ORTHOG-6PLATES · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327370867), received between Aug 13, 2024 and Sep 12, 2025 — classified as 2 injuries, 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Fracture; Fracture
InjurySep 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE DEVICE DID NOT FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20299636 ↗InjuryAug 20, 2024Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002854 ↗MalfunctionAug 13, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING SURGERY, THE PLATES NEEDED ADJUSTMENT. THIS CAUSED A SURGICAL DELAY OF 20 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977174 ↗
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- 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.