MAUDE Adverse Event Report: Nobel Biocare AB Replace Select TC RP 4.0x(13+3)mm; Endosseous Dental Implant

Catalog Number	36291
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: Replace Select TC RP 4.0x(13+3)mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Nobel Biocare AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 50678143
• Report Number: 2027971-2026-125414
• Device Sequence Number: 14781340
• Product Code: DZE
• UDI-Device Identifier: 07332747160437
• UDI-Public: (01)07332747160437(10)12255033(17)291006
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/08/2026
• Report Date (Section F): 09/08/2026

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 Catalogue Number: 36291
• Device Lot Number: 12255033
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2026
• 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: 71 YR
• Patient Sex: Male