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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG BRÅNEMARK SYSTEM MK III RP 3.75X11.5MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG BRÅNEMARK SYSTEM MK III RP 3.75X11.5MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 28886
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code Numbness (2415)
Date of Event 11/02/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Surface defect on component.
 
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Brand Name
BRÅNEMARK SYSTEM MK III RP 3.75X11.5MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
västra hamngatan 1
göteborg 41117
SW  41117
MDR Report Key23537824
Report Number2027971-2025-146296
Device Sequence Number13308599
Product Code DZE
UDI-Device Identifier07332747004700
UDI-Public(01)07332747004700(10)644822(17)081119
Combination Product (Y/N)N
Initial Reporter CountrySP
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section F) 11/12/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/19/2008
Device Catalogue Number28886
Device Lot Number644822
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/04/2025
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/12/2025
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 Age75 YR
Patient SexMale
Date Report Sent to FDA11/12/2025
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