MAUDE Adverse Event Report: JJGC S.A. CM TITAMAX EX ACQUA IMPL TI 3.5X15; ENDOSSEOUS DENTAL IMPLANT

Model Number	140.664
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2017 in ada 4.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2021, loss of osseointegration was verified.The device was forwarded to the manufacturer.There were no patient operative or post-operative complications reported.

• Brand Name: CM TITAMAX EX ACQUA IMPL TI 3.5X15
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 12534079
• Report Number: 0001222315-2021-15964
• Device Sequence Number: 1428918
• Product Code: DZE
• UDI-Device Identifier: 07899878016762
• UDI-Public: 07899878016762
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/27/2021
• Report Date (Section F): 09/03/2021

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: 01/21/2019
• Device Model Number: 140.664
• Device Catalogue Number: 140.664
• Device Lot Number: 91100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2021
• Device Age: 87 MO
• Event Location: Other
• Date Report to Manufacturer: 09/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR