MAUDE Adverse Event Report: HAGER & MEISINGER GMBH INFINITY OCTAGON IMPLANT; DENTAL IMPLANT

Model Number	504112BL
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good oral hygiene is recommended for a successful and long-lasting osseointegration.An evaluation of the implant by the manufacturer has shown no indications of a product defect or unknown risks.
Event or Problem Description
Inadequate bone qualiy/bone quantity and poor oral hygiene were reported.Bone quality at the time of implant failure type ii.Time of loss in relation to the implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmetation procedure was not performed at the time of surgery.Patient is a smoker.

• Brand Name: INFINITY OCTAGON IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss nordrhein-westfalen, germany D-414 68; GM D-41468
• MDR Report Key: 9232361
• Report Number: 1287163-2019-00674
• Device Sequence Number: 14074380
• Product Code: DZE
• UDI-Device Identifier: E0HM504112BL1
• UDI-Public: E0HM504112BL1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/21/2019
• Report Date (Section F): 09/30/2019

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 Model Number: 504112BL
• Device Catalogue Number: 504112BL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2019
• Event Location: Other
• Date Report to Manufacturer: 09/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR