MAUDE Adverse Event Report: BRÅNEMARK SYSTEM MK III RP 3.75X8.5MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	28884
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Implant failed due to a failure to osseointegrate.

• Brand Name: BRÅNEMARK SYSTEM MK III RP 3.75X8.5MM
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12722821
• Report Number: 9611993-2021-102269
• Device Sequence Number: 17070438
• Product Code: DZE
• UDI-Device Identifier: 07332747004687
• UDI-Public: (01)07332747004687(10)12103086(17)221231
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K925765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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: 12/31/2022
• Device Model Number: 28884
• Device Catalogue Number: 28884
• Device Lot Number: 12103086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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: 69 YR