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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELACTIVE INTERNAL RP 5.0X15MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG NOBELACTIVE INTERNAL RP 5.0X15MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 34140
Medical Device Problem Code Osseointegration Problem (3003)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/09/2026
Type of Reportable Event Serious Injury
Event or Problem Description
Lack of stability during placement.
 
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Brand Name
NOBELACTIVE INTERNAL RP 5.0X15MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
västra hamngatan 1
göteborg 41117
SW  41117
MDR Report Key25554419
Report Number2027971-2026-093820
Device Sequence Number5584951
Product Code DZE
UDI-Device Identifier07332747160130
UDI-Public(01)07332747160130(10)13127561(17)270129
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2026
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section F) 06/18/2026
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 Catalogue Number34140
Device Lot Number13127561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/10/2026
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/18/2026
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 Age77 YR
Patient SexMale
Date Report Sent to FDA06/18/2026
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