MAUDE Adverse Event Report: Nobel Biocare AB Replace Select Tapered TiU NP 3.5x11.5mm; Endosseous Dental Implant

Catalog Number	36105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Component fractured.

• 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 Key: 50110920
• Report Number: 2027971-2026-112437
• Device Sequence Number: 10728588
• Product Code: DZE
• UDI-Device Identifier: 07332747160307
• UDI-Public: (01)07332747160307(10)13152035(17)280528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 36105
• Device Lot Number: 13152035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female