MAUDE Adverse Event Report: HAGER & MEISINGER GMBH OKTAGON BLT RC IMPLANT 4.1X10MM; DENTAL IMPLANT

Model Number	3624002DU0000
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Missing osseointegration.

• Brand Name: OKTAGON BLT RC IMPLANT 4.1X10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer (Section G): HAGER & MEISINGER GMBH; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• Manufacturer Contact: eva schaffert ; hansemannstr. 10; neuss, nordrhein-westfalen 41468 ; GM 41468
• MDR Report Key: 13646409
• Report Number: 8010516-2022-00010
• Device Sequence Number: 5801286
• Product Code: DZE
• UDI-Device Identifier: E0HM240021
• UDI-Public: +E0HM240021/$C03208/14D20260430O
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/22/2022

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 Expiration Date: 04/30/2026
• Device Model Number: 3624002DU0000
• Device Catalogue Number: 24002
• Device Lot Number: C03208
• 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: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2021
• 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: 66 YR
• Patient Sex: Unknown