MAUDE Adverse Event Report: NOBEL BIOCARE AB BRÅNEMARK SYSTEM® ZYGOMA TIUNITE 35MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	34724
Medical Device Problem Codes	Failure to Osseointegrate (1863); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Sinus Perforation (2277)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to sinus perforation.

• Brand Name: BRÅNEMARK SYSTEM® ZYGOMA TIUNITE 35MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer (Section G): NOBEL BIOCARE AB; dimbovägen 2; karlskoga 69151 ; SW 69151
• Manufacturer Contact: gayco meel ; popeweg 72; venlo 5928 -SC ; NL 5928 SC ; 623202508
• MDR Report Key: 16846997
• Report Number: 9611993-2023-063190
• Device Sequence Number: 7548039
• Product Code: DZE
• UDI-Device Identifier: 07332747013467
• UDI-Public: (01)07332747013467(10)12046740(17)200715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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 Expiration Date: 07/15/2020
• Device Model Number: 34724
• Device Catalogue Number: 34724
• Device Lot Number: 12046740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• 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: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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: 58 YR
• Patient Sex: Female