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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG BRÅNEMARK SYSTEM MK III TIU RP 3.75X7MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG BRÅNEMARK SYSTEM MK III TIU RP 3.75X7MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 28911
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Implant Pain (4561)
Date of Event 12/02/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Failure to osseointegrate.
 
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Brand Name
BRÅNEMARK SYSTEM MK III TIU RP 3.75X7MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
västra hamngatan 1
göteborg 41117
SW  41117
MDR Report Key23900148
Report Number2027971-2025-164565
Device Sequence Number21429726
Product Code DZE
UDI-Device Identifier07332747159448
UDI-Public(01)07332747159448(10)12228859(17)280823
Combination Product (Y/N)N
Initial Reporter CountrySP
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
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section F) 12/26/2025
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 Number28911
Device Lot Number12228859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/18/2025
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/26/2025
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 Age50 YR
Patient SexMale
Date Report Sent to FDA12/26/2025
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