Medicon 68.99.30ARecalls & reported problems
Medicon eG. Chirurgiemechaniker-Genossenschaft · Aarhus screw 1.6 bracket-head 8.0/1.5/11.2mm p/5 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046826385491), received between Nov 9, 2018 and Jan 7, 2019 — classified as 3 malfunctions.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture3
- Device Handling Problem2
Patient problems
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2019Fracture; Fracture
THE ORTHODONTIC SCREW BROKE AFTER SUCCESSFUL IMPLANTATION WHEN THE USER ATTEMPTED TO REMOVE THE IMPLANTATION SLEEVE USING THE DEDICATED SCREWDRIVER. HOWEVER, THE SLEEVE WAS FIRMLY LODGED ON THE SCREW HEAD, THE SCREWDRIVER BLADE BROKE, AND ANOTHER INSTRUMENT WAS REQUIRED TO FORCIBLY REMOVE THE SLEEVE.
Patient problems: Failure of Implant
MAUDE report 8221831 ↗MalfunctionNov 9, 2018Fracture; Device Handling Problem; Fracture; Device Handling Problem
THE ORTHODONTIC SCREW BROKE AS IT WAS BEING INSERTED INTO THE PATIENT'S JAW. THE BROKEN PIECE WAS REMOVED IMMEDIATELY. NO HARM TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8055194 ↗MalfunctionNov 9, 2018Fracture; Device Handling Problem; Fracture; Device Handling Problem
THE ORTHODONTIC SCREW BROKE AS IT WAS BEING INSERTED INTO THE PATIENT'S JAW. THE BROKEN PIECE WAS REMOVED IMMEDIATELY. NO HARM TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8055191 ↗
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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 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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