NA 78-92002Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · FACIAL ID-ORTHOG-2PLATES · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327370935), received between Sep 21, 2020 and Mar 23, 2026 — classified as 5 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture6
- Inadequacy of Device Shape and/or Size6
- Adverse Event Without Identified Device or Use Problem1
- Nonstandard Device1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information7
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2026Fracture
MalfunctionFeb 12, 2026Patient-Device Incompatibility
IT WAS REPORTED THAT PLACEMENT OF THE FOSSA COMPONENT WAS PROBLEMATIC. THE MANDIBLE FRACTURED DURING MANUAL CUTTING BY THE SURGEON, LEADING TO INADEQUATE FIT OF THE FOSSA COMPONENT. PLATE # 2 OF THE FACIAL ID PLATES WAS NOT IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24323472 ↗MalfunctionNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO MOBILIZE THE MANDIBLE ENOUGH TO GET THE INTERMEDIATE SPLINT IN PLACE, AND THE LEFORT WAS NOT COMPLETED AS THEY WERE NOT SURE IF THEY WOULD GET THE CORRECT RESULT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23656748 ↗MalfunctionOct 15, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23300371 ↗MalfunctionAug 29, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO NEW INFORMATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22921404 ↗InjurySep 10, 2024Fracture; Fracture
IT WAS REPORTED THAT THE DEVICES WERE BROKEN POSTOPERATIVELY. THE DEVICES WERE REMOVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20182379 ↗MalfunctionSep 4, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING SURGERY, THE PLATE DID NOT FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140889 ↗InjuryApr 23, 2024Fracture; Fracture
IT WAS REPORTED THAT IT WAS DISCOVERED POST OPERATIVELY THE CUSTOM MAXILLA PLATES WERE BROKEN. THERE WILL BE A REVISION SURGERY TO REMOVE THE BROKEN PLATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163699 ↗MalfunctionJun 28, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE SURGERY THE SURGEON FOUND THE PLATE DID NOT FIT WELL AGAINST THE BONE. WHEN A SCREW WAS PLACED, THE PLATE WOULD COME OFF THE BONE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND NO REPORTED ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17221623 ↗MalfunctionFeb 10, 2023Nonstandard Device; Inadequacy of Device Shape and/or Size; Nonstandard Device; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE CASE, THE SURGEON NEEDED TO MAKE ADJUSTMENTS FOR THE DEVICES TO FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16352627 ↗InjuryJul 19, 2022Fracture; Fracture
IT WAS REPORTED THAT IT WAS DISCOVERED DURING A POST-OP SCAN, THAT THE FACIAL ID PLATE HAD BROKEN. THERE IS NO OTHER INFORMATION KNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15053522 ↗MalfunctionFeb 17, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE FACIAL ID CHIN PLATE WAS MANUFACTURED WITH THE INCORRECT SYSTEM FOR THE PROCEDURE. THE SURGEON REQUIRED A 2.0MM THICK MINI PLATE BUT THE PLATE WAS 1.7MM THICK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13549031 ↗MalfunctionMay 4, 2021Fracture; Fracture
IT WAS REPORTED THAT THE PLATE IS BROKEN AND WILL REMAIN IMPLANTED. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11769473 ↗InjurySep 21, 2020Fracture; Fracture
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT A BROKEN PLATE AND INFECTION WAS DISCOVERED POST OPERATIVELY, AND A REVISION SURGERY WAS PERFORMED TO HAVE PLATE REMOVED. THE CUSTOMER BELIEVES THE STRYKER PRODUCT DID NOT CAUSE THE INFECTION BUT RATHER, A WOUND INFECTION. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 10561138 ↗
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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