MAUDE Adverse Event Report: NOBEL BIOCARE AB BRÅNEMARK SYSTEM MK III TIU WP 5.0X7MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	28925
Medical Device Problem Codes	Failure to Osseointegrate (1863); Missing Information (4053)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to trauma / clinical complication only.

• Brand Name: BRÅNEMARK SYSTEM MK III TIU WP 5.0X7MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• MDR Report Key: 17291008
• Report Number: 2027971-2023-098866
• Device Sequence Number: 5606903
• Product Code: DZE
• UDI-Device Identifier: 07332747001297
• UDI-Public: (01)07332747001297(10)12095002(17)220907
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 07/10/2023

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: 09/07/2022
• Device Model Number: 28925
• Device Catalogue Number: 28925
• Device Lot Number: 12095002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2023
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2023
• 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: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/10/2023