MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG NOBELSPEEDY REPLACE 6.0 6X10MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	32191
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Loss of osseointegration.

• Brand Name: NOBELSPEEDY REPLACE 6.0 6X10MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB GÖTEBORG; västra hamngatan 1; göteborg 41117 ; SW 41117
• MDR Report Key: 22985187
• Report Number: 2027971-2025-121555
• Device Sequence Number: 13005005
• Product Code: DZE
• UDI-Device Identifier: 07332747001600
• UDI-Public: (01)07332747001600(10)12021270(17)190419
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/05/2025

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: 04/19/2019
• Device Catalogue Number: 32191
• Device Lot Number: 12021270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2025
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• 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: 52 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/05/2025