Medicon 68.99.31ARecalls & reported problems
Medicon eG. Chirurgiemechaniker-Genossenschaft · Aarhus screw 1.6 bracket-head 8.0/2.5/12.2mm p/5 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046826385514), received between Jun 10, 2020 and Jun 10, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2020Fracture; Fracture
THE SCREW BROKE AT A DEPTH OF 5 MM DURING THE SCREWING PROCESS. 0.8 MM OF THE SCREW TIP BROKE OFF. ACCORDING TO THE DOCTOR, THE SCREW TIP REMAINS IN THE PATIENT'S JAW AND SURGERY WILL BE NECESSARY TO REMOVE THE DEVICE FRAGMENT. (DEVICE 2 OF 2)
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10136828 ↗
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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 13, 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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