MAUDE Adverse Event Report: NOBEL BIOCARE AB GÖTEBORG BRÅNEMARK SYSTEM® ZYGOMA TIUNITE 40MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	34735
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Failure to osseointegrate.

• Brand Name: BRÅNEMARK SYSTEM® ZYGOMA TIUNITE 40MM
• 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: 20690861
• Report Number: 9611993-2024-124882
• Device Sequence Number: 8659261
• Product Code: DZE
• UDI-Device Identifier: 07332747160178
• UDI-Public: (01)07332747160178(10)12216937(17)280116
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K050641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial

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 Catalogue Number: 34735
• Device Lot Number: 12216937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2023
• 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: 56 YR
• Patient Sex: Male