MAUDE Adverse Event Report: HAGER & MEISINGER GMBH OCTAGON BONE LEVEL IMPL. BLT 4.1X10MM; DENTAL IMPLANT

Model Number	3624002DU0ACE
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/25/2021
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.

• Brand Name: OCTAGON BONE LEVEL IMPL. BLT 4.1X10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 12567138
• Report Number: 8010516-2021-00061
• Device Sequence Number: 3473429
• Product Code: DZE
• UDI-Device Identifier: E0HM240021
• UDI-Public: +E0HM240021/$C03207/14D20260228S
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 3624002DU0ACE
• Device Catalogue Number: 24002
• Device Lot Number: C03207
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR