MAUDE Adverse Event Report: HAGER & MEISINGER GMBH TISSUE LEVEL IMPLANT REGULAR PLATFORM Ø4,8X10; DENTAL IMPLANT

Model Number	3650347DU0ACE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
Event or Problem Description
Missing primary stability."buccal defect surgeon tried 3 implants; none of them engaged, probably not enough thread, decided to graft first and wait 3-4 month" see also reports 8010516-2022-00113 and 8010516-2022-00114.

• Brand Name: TISSUE LEVEL IMPLANT REGULAR PLATFORM Ø4,8X10
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss 41468
• Manufacturer (Section G): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer Contact: wiebke eckhardt ; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 15333218
• Report Number: 8010516-2022-00112
• Device Sequence Number: 7020710
• Product Code: DZE
• UDI-Device Identifier: E0HM5048101
• UDI-Public: +E0HM5048101/$B41510/14D20230331/Q19
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122807
• 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: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 3650347DU0ACE
• Device Catalogue Number: 504810
• Device Lot Number: B41510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male