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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELPEARL TAPERED RP 4.2X12MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG NOBELPEARL TAPERED RP 4.2X12MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 300757
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 07/31/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Failure to osseointegrate.
 
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Brand Name
NOBELPEARL TAPERED RP 4.2X12MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
bohusgatan 15
göteborg 41139
SW  41139
MDR Report Key21578333
Report Number2027971-2025-053798
Device Sequence Number9467733
Product Code DZE
UDI-Device Identifier07640161395138
UDI-Public(01)07640161395138(10)3066257(17)280618
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Device Explanted Year2024
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section F) 03/11/2025
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 Number300757
Device Lot Number3066257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/23/2024
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/11/2025
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; Required Intervention;
Patient Age52 YR
Patient SexMale
Date Report Sent to FDA03/11/2025
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