MAUDE Adverse Event Report: Nobel Biocare AB Göteborg NobelReplace CC RP 5.0x8mm; Endosseous Dental Implant

Catalog Number	36710
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: NobelReplace CC RP 5.0x8mm
• Common Device Name: Endosseous Dental Implant
• Manufacturer (Section D): Nobel Biocare AB Göteborg; västra hamngatan 1; göteborg 41117 ; SW 41117
• Manufacturer (Section G): Nobel Biocare AB Göteborg; västra hamngatan 1; göteborg 41117 ; SW 41117
• Manufacturer Contact: gayco meel ; heierkerweg 1b; venlo 5928 -RM ; NL 5928 RM ; +031()623202508
• MDR Report Key: 50310456
• Report Number: 9611993-2026-120530
• Device Sequence Number: 18335526
• Product Code: DZE
• UDI-Device Identifier: 07332747035674
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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 Date: 08/16/2023
• Device Catalogue Number: 36710
• Device Lot Number: 13070662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female