NA 55-10503Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · MINI PLATE, STRAIGHT, LONG BAR · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 04546540366214), received between May 24, 2018 and Jul 11, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (4 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
- Fracture4
Patient problems
- No Known Impact Or Consequence To Patient2
- Bone Fracture(s)1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2022Fracture; Fracture
IT WAS REPORTED THAT IT WAS NOTICED DURING A POST OP SCAN THAT THE PLATE WAS BROKEN. THERE WILL BE A REVISION SURGERY PERFORMED TO REMOVE THE PLATE.
Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 14980823 ↗MalfunctionMay 21, 2021Fracture; Fracture
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT 2 WEEKS AFTER IMPLANTATION, THE PLATES WERE DISCOVERED AS BROKEN. THERE IS A REVISION SURGERY TO TAKE PLACE. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 11866748 ↗MalfunctionDec 6, 2018Fracture
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT IT WAS FOUND AFTER A SURGICAL PROCEDURE AN IMPLANT PLATE WAS FRACTURED. THE FRACTURE WAS DISCOVERED POST-OPERATIVELY, BUT IT IS NOT KNOWN WHEN THE FRACTURE ACTUALLY OCCURRED. THE ORIGINAL PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY WITHOUT A DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE, AND A REVISION SURGERY WAS PLANNED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8139005 ↗InjuryMay 24, 2018Fracture
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT AFTER AN INITIAL CONDYLE FRACTURE SURGERY WAS COMPLETED A REVISION SURGERY TOOK PLACE TO REMOVE THE PLATE.. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THE REVISION SURGERY, WHICH WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7541628 ↗
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 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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