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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAGER & MEISINGER GESELLSCHAFT HAGER & MEISINGER GESELLSCHAFT; DENTAL IMPLANT
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HAGER & MEISINGER GESELLSCHAFT HAGER & MEISINGER GESELLSCHAFT; DENTAL IMPLANT Back to Search Results
Model Number 504112
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/18/2026
Type of Reportable Event Serious Injury
Event or Problem Description
Implant failed to osseointegrate.
 
Additional Manufacturer Narrative
The report is being transmitted now due to lack of information to the actual legal manufacture of the product.The distributor records were unable to locate during initial reporting time frame.With the new updated information the correct legal manufacture could be set up and file within the system for current and future entry.
 
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Brand Name
HAGER & MEISINGER GESELLSCHAFT
Common Device Name
DENTAL IMPLANT
Manufacturer (Section D)
HAGER & MEISINGER GESELLSCHAFT
hansemannstrasse 10
neuss 41468
GA  41468
MDR Report Key24759124
Report Number1287163-2026-00001
Device Sequence Number15630185
Product Code DZE
UDI-Device IdentifierE0HM5041121
UDI-PublicE0HM5041121
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K122807
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Report Source Company Representative
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 03/20/2026
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 Model Number504112
Device Catalogue Number504112
Device Lot NumberB94256
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date12/16/2025
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/01/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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