MAUDE Adverse Event Report: NOBEL BIOCARE AB BRÅNEMARK SYSTEM MK III TIU RP 4.0X7MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	28918
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Failure of Implant (1924)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to abcess.

• Brand Name: BRÅNEMARK SYSTEM MK III TIU RP 4.0X7MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 19568929
• Report Number: 2027971-2024-093393
• Device Sequence Number: 12290330
• Product Code: DZE
• UDI-Device Identifier: 07332747001228
• UDI-Public: (01)07332747001228(10)655534(17)100331
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 06/19/2024

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: 03/31/2010
• Device Catalogue Number: 28918
• Device Lot Number: 655534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/10/2024
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• 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: 59 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/19/2024