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

Model Number	503310BL
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Swelling (2091)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This implant loss suggests that the source of the problem was likely to stem from no osseointegration.Additionally, other factors that may have contributed to the implant failure includes bone condition, patient oral hygiene, overall health or behavior.Proper intended use of the implant is described in its instructions for use.Physical analysis cannot be performed.
Event or Problem Description
Bone quality at the time of implant failure type ii.Bleeding and swelling were reported.Time of loss in relation tot he implantation was before prosthetic restoration.Primary stability was achieved.Osseointegration was not achieved.Augmentation procedure was not performed at the time of surgery.

• Brand Name: INFINITY OCTAGON IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstrasse 10; neuss, D-414 68; GM D-41468
• MDR Report Key: 9335322
• Report Number: 1287163-2019-52304
• Device Sequence Number: 2243437
• Product Code: DZE
• UDI-Device Identifier: E0HM503310BL1
• UDI-Public: E0HM503310BL1
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/15/2019
• Report Date (Section F): 11/15/2019

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: 503310BL
• Device Catalogue Number: 503310BL
• Device Lot Number: B41500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2019
• Event Location: Other
• Date Report to Manufacturer: 11/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/18/2019
• 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: 66 YR