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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELSPEEDY GROOVY NP 3.3X10MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG NOBELSPEEDY GROOVY NP 3.3X10MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 33123
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/19/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Loss of osseointegration.
 
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Brand Name
NOBELSPEEDY GROOVY NP 3.3X10MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
bohusgatan 15
göteborg 41139
SW  41139
MDR Report Key21553285
Report Number2027971-2025-052946
Device Sequence Number4643562
Product Code DZE
UDI-Device Identifier07332747001440
UDI-Public(01)07332747001440(10)12102368(17)221222
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
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) 03/07/2025
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 Expiration Date12/22/2022
Device Catalogue Number33123
Device Lot Number12102368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/27/2025
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/07/2025
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 Age74 YR
Patient SexMale
Date Report Sent to FDA03/07/2025
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