MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG BRÅNEMARK SYSTEM MK IV TIU RP 4.0X10MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	28934
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Abscess (1690); Failure of Implant (1924)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.
Additional Manufacturer Narrative
The material number has been updated, which is reflected in this follow up report.
Event or Problem Description
Loss of osseointegration.The material number has been updated, which is reflected in this follow up report.

• Brand Name: BRÅNEMARK SYSTEM MK IV TIU RP 4.0X10MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• Manufacturer (Section G): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 21702907
• Report Number: 9611993-2025-062212
• Device Sequence Number: 11890926
• Product Code: DZE
• UDI-Device Identifier: 07332747001488
• UDI-Public: (01)07332747001488(10)12117874(17)230812
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K974828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup

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: 08/12/2023
• Device Catalogue Number: 28934
• Device Lot Number: 12117874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1999
• 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: 62 YR
• Patient Sex: Male