MAUDE Adverse Event Report: MEDENTIKA GMBH MINICONE IMPLANT D 2.6 L 10; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	5-01-08
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2023 in ada 6.On (b)(6) 2023, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• Brand Name: MINICONE IMPLANT D 2.6 L 10
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): MEDENTIKA GMBH; hammweg 8-10; huegelsheim 76549 ; GM 76549
• MDR Report Key: 18121417
• Report Number: 0001222315-2023-028132
• Device Sequence Number: 7540626
• Product Code: DZE
• UDI-Device Identifier: 04251574849724
• UDI-Public: 04251574849724
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/13/2023
• Report Date (Section F): 10/20/2023

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 Expiration Date: 12/07/2025
• Device Catalogue Number: 5-01-08
• Device Lot Number: L0074130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2023
• Device Age: 34 MO
• Event Location: Other
• Date Report to Manufacturer: 10/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• 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: 74 YR
• Patient Sex: Female