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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG REPLACE SELECT STRAIGHT TIU NP 3.5X10MM; ENDOSSEOUS DENTAL IMPLANT
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NOBEL BIOCARE AB GÖTEBORG REPLACE SELECT STRAIGHT TIU NP 3.5X10MM; ENDOSSEOUS DENTAL IMPLANT Back to Search Results
Catalog Number 28946
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 01/14/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Component fractured.
 
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Brand Name
REPLACE SELECT STRAIGHT TIU NP 3.5X10MM
Common Device Name
ENDOSSEOUS DENTAL IMPLANT
Manufacturer (Section D)
NOBEL BIOCARE AB GÖTEBORG
bohusgatan 15
göteborg 41139
SW  41139
MDR Report Key21269175
Report Number2027971-2025-039075
Device Sequence Number8450918
Product Code DZE
UDI-Device Identifier07332747022490
UDI-Public(01)07332747022490(10)12001862(17)180712
Combination Product (Y/N)N
Initial Reporter CountryIT
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 01/29/2025
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? Yes
Operator of Device Health Professional
Device Expiration Date07/12/2018
Device Catalogue Number28946
Device Lot Number12001862
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/22/2025
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/29/2025
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 Age69 YR
Patient SexFemale
Date Report Sent to FDA01/29/2025
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