MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELREPLACE CC PMC RP 5.0X8MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37295
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: NOBELREPLACE CC PMC 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 ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 22659722
• Report Number: 9611993-2025-097271
• Device Sequence Number: 8752724
• Product Code: DZE
• UDI-Device Identifier: 07332747073546
• UDI-Public: (01)07332747073546(10)13025710(17)201127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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: 11/27/2020
• Device Catalogue Number: 37295
• Device Lot Number: 13025710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2015
• 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: 51 YR
• Patient Sex: Female