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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDENTIKA GMBH MINICONE IMPLANT D 2.6 L 10; ENDOSSEOUS DENTAL IMPLANT
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MEDENTIKA GMBH MINICONE IMPLANT D 2.6 L 10; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 5-01-08
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/04/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in ada 9.On (b)(6) 2024, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
 
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Brand Name
MINICONE IMPLANT D 2.6 L 10
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
MEDENTIKA GMBH
hammweg 8-10
huegelsheim 76549
GM  76549
MDR Report Key21506592
Report Number0001222315-2025-000560
Device Sequence Number4401001
Product Code DZE
UDI-Device Identifier04251574849724
UDI-Public04251574849724
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/03/2025
Report Date (Section F) 02/06/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number5-01-08
Device Lot NumberL0091977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/03/2025
Device Age38 MO
Event Location Other
Date Report to Manufacturer02/06/2025
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/03/2025
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age25 YR
Patient SexMale
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