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

Model Number	28924
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a loss of osseointegration.

• Brand Name: BRÅNEMARK SYSTEM MK III TIU RP 4.0X18MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12723465
• Report Number: 2027971-2021-124851
• Device Sequence Number: 3855513
• Product Code: DZE
• UDI-Device Identifier: 07332747001280
• UDI-Public: (01)07332747001280(10)639646(17)080313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section F): 10/29/2021

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: 03/13/2008
• Device Model Number: 28924
• Device Catalogue Number: 28924
• Device Lot Number: 639646
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/28/2021
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Date Report Sent to FDA: 10/29/2021