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

Model Number	28918
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to loss of osseointegration.

• 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
• 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: 16863588
• Report Number: 9611993-2023-063728
• Device Sequence Number: 5385605
• Product Code: DZE
• UDI-Device Identifier: 07332747001228
• UDI-Public: (01)07332747001228(10)686575(17)121226
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K022562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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: 12/26/2012
• Device Model Number: 28918
• Device Catalogue Number: 28918
• Device Lot Number: 686575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• 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: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2008
• 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: 52 YR
• Patient Sex: Female