MAUDE Adverse Event Report: BRÅNEMARK SYSTEM MK IV TIU RP 4.0X18MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	28938
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Pain (1994)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a loss of osseointegration.

• Brand Name: BRÅNEMARK SYSTEM MK IV TIU RP 4.0X18MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12740590
• Report Number: 9611993-2021-103191
• Device Sequence Number: 4703733
• Product Code: DZE
• UDI-Device Identifier: 07332747013269
• UDI-Public: (01)07332747013269(10)649152(17)090813
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K022562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2021
• 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: 08/13/2009
• Device Model Number: 28938
• Device Catalogue Number: 28938
• Device Lot Number: 649152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2004
• 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: 65 YR