MAUDE Adverse Event Report: EXT HEX ZYGOMATIC IMPL TI 50; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.453
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 3, failure occurred upon insertion.Primary stability not achieved and implant surface not completely covered with bone.Patient presented with fair oral hygiene.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• Brand Name: EXT HEX ZYGOMATIC IMPL TI 50
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• MDR Report Key: 12633550
• Report Number: 0001222315-2021-17221
• Device Sequence Number: 3421874
• Product Code: DZE
• UDI-Device Identifier: 07898237567310
• UDI-Public: 07898237567310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/14/2021
• Report Date (Section F): 09/20/2021

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: 09/01/2022
• Device Model Number: 109.453
• Device Catalogue Number: 109.453
• Device Lot Number: 184274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2021
• Device Age: 47 MO
• Event Location: Other
• Date Report to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2021
• 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: 65 YR