Medicon 68.74.14Recalls & reported problems
Medicon eG. Chirurgiemechaniker-Genossenschaft · Ti Mini plate 4 holes short int sect 8mm p/2 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046826121204), received between Jan 4, 2019 and Jan 7, 2019 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture2
- Inadequacy of Device Shape and/or Size2
Patient problems
- Failure of Implant2
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2019Fracture; Inadequacy of Device Shape and/or Size; Fracture; Inadequacy of Device Shape and/or Size
ON (B)(6) 2017 - TWO BONE PLATES IMPLANTED IN FRACTURED MANDIBLE. ON (B)(6) 2017 - CONTROL X-RAY, BONE PLATES INTACT. ON (B)(6) 2017 - PANORAMIC RADIOGRAPH REVEALS FRACTURE OF THE UPPER BONE PLATE (PLATE #1). PATIENT EXPERIENCING PAIN. ON (B)(6) 2017 - FRACTURE OF BONE PLATE #2 (CURRENT MDR REPORT) IS DETECTED. ON (B)(6) 2018 - BOTH PLATES EXPLANTED. NO ALVEOLAR FISTULA, NO INFECTION, NO PATHOLOGIC MOBILITY. CONSOLIDATION FINE. ON (B)(6) 2018 - NEW, THICKER 2-MM BONE PLATES IMPLANTED. SIGNS OF INFECTION DURING FOLLOW-UP. NEW PLATES INTACT. STANDARD POSTOPERATIVE PROTOCOL FOLLOWED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 8221401 ↗MalfunctionJan 4, 2019Fracture; Inadequacy of Device Shape and/or Size; Fracture; Inadequacy of Device Shape and/or Size
ON (B)(6) 2017 - TWO BONE PLATES IMPLANTED IN FRACTURED MANDIBLE. ON (B)(6) 2017 - CONTROL X-RAY, BONE PLATES INTACT. ON (B)(6) 2017 - PANORAMIC RADIOGRAPH REVEALS FRACTURE OF THE UPPER BONE PLATE (PLATE #1, CURRENT MDR REPORT). PATIENT EXPERIENCING PAIN. ON (B)(6) 2017 - FRACTURE OF BONE PLATE #2 IS DETECTED. ON (B)(6) 2018 - BOTH PLATES EXPLANTED. NO ALVEOLAR FISTULA, NO INFECTION, NO PATHOLOGIC MOBILITY. CONSOLIDATION FINE. ON (B)(6) 2018 - NEW, THICKER 2-MM BONE PLATES IMPLANTED. SIGNS OF INFECTION DURING FOLLOW-UP. NEW PLATES INTACT. STANDARD POSTOPERATIVE PROTOCOL FOLLOWED.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 8217500 ↗
Other PLATE, BONE devices
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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 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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