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

Model Number	504810BL
Medical Device Problem Codes	Failure to Osseointegrate (1863); Osseointegration Problem (3003); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Same day spinner.

• Brand Name: INFINITY OCTAGON BONE LEVEL IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, 41468 ; GM 41468
• Manufacturer (Section G): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, postfach 41468 ; GM 41468
• Manufacturer Contact: james weatherby ; 1034 pearl street; brockton, MA 02301 ; 8004413100
• MDR Report Key: 16988135
• Report Number: 1287163-2022-02097
• Device Sequence Number: 12501939
• Product Code: DZE
• UDI-Device Identifier: E0HM504810BL1
• UDI-Public: E0HM504810BL1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 504810BL
• Device Catalogue Number: 504810BL
• Device Lot Number: C22356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 34 YR
• Patient Sex: Prefer Not To Disclose