NA 55-15911Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PRIMARY MAND RECON PLATE, WITH TEMPLATE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540356376), received between Sep 5, 2018 and Jun 20, 2023 — classified as 3 injuries.
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.
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
- Necrosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PLATE WAS DISCOVERED FRACTURED POST OPERATIVE. THERE WAS A REVISION SURGERY TO REMOVE THE PLATE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17164853 ↗InjuryJun 15, 2022Fracture; Fracture
IT WAS REPORTED THAT THE PLATE WAS BROKEN AND A REVISION SURGERY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14697610 ↗InjurySep 5, 2018Fracture
IT WAS REPORTED THAT RIGHT MANDIBULAR OSTEONECROSIS OCCURRED WITHIN THE PATIENT, AS WELL AS A MANDIBULAR RECONSTRUCTION PLATE FRACTURE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE FRACTURED PLATE AND IMPLANT ANOTHER MANDIBULAR RECONSTRUCTION PLATE.
Patient problems: Necrosis
MAUDE report 7847855 ↗
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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