MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG REPLACE SELECT TAPERED PMC 6.0 6X11.5MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	37317
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration: (b)(6) 2025 21:47:23 cet (5001035).Mobility, tenderness and slight purulent discharge were added as conditions involved.Implant expired was (b)(6) 2023, however it was used on the patient (b)(6) 2025.Three attempts were made by customer service to obtain more information regarding this event but no answer from the customer has been received.

• Brand Name: REPLACE SELECT TAPERED PMC 6.0 6X11.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; bohusgatan 15; göteborg 41139 ; SW 41139
• MDR Report Key: 22425581
• Report Number: 2027971-2025-066601
• Device Sequence Number: 7918811
• Product Code: DZE
• UDI-Device Identifier: 07332747073324
• UDI-Public: (01)07332747073324(10)12116313(17)230721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 07/08/2025

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: 07/21/2023
• Device Catalogue Number: 37317
• Device Lot Number: 12116313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/08/2025