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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Nobel Biocare AB Replace Select Tapered TiU NP 3.5x11.5mm; Endosseous Dental Implant
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Nobel Biocare AB Replace Select Tapered TiU NP 3.5x11.5mm; Endosseous Dental Implant Back to Search Results
Catalog Number 36105
Medical Device Problem Code Failure to Osseointegrate (1863)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/24/2026
Type of Reportable Event Serious Injury
Event or Problem Description
Failure to osseointegrate.
 
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Brand Name
Replace Select Tapered TiU NP 3.5x11.5mm
Common Device Name
Endosseous Dental Implant
Manufacturer (Section D)
Nobel Biocare AB
dimbovägen 2
karlskoga 69151
SW  69151
MDR Report Key50110670
Report Number2027971-2026-112313
Device Sequence Number10321009
Product Code DZE
UDI-Device Identifier07332747160307
UDI-Public(01)07332747160307(10)444087(17)150617
Combination Product (Y/N)N
Initial Reporter CountrySP
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2026
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 08/01/2026
Report Date (Section F) 08/01/2026
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 Expiration Date06/17/2015
Device Catalogue Number36105
Device Lot Number444087
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/28/2026
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/24/2026
Event Location Outpatient Treatment Facility
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/03/2026
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age46 YR
Patient SexMale
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