MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPL TI 3.5X16; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.684
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2016 in ada 10.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2023, loss of osseointegration was verified.Patient presented with fair oral hygiene.The device was forwarded to the manufacturer.At the event the patient experienced: infection and pain.No further patient complications were reported.

• Brand Name: CM DRIVE IMPL TI 3.5X16
• 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: 16487899
• Report Number: 0001222315-2023-005243
• Device Sequence Number: 6844721
• Product Code: DZE
• UDI-Device Identifier: 07898237569222
• UDI-Public: 07898237569222
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 03/06/2023
• Report Date (Section F): 02/09/2023

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: 01/28/2020
• Device Model Number: 109.684
• Device Catalogue Number: 109.684
• Device Lot Number: 800173816I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2023
• Device Age: 97 MO
• Event Location: Other
• Date Report to Manufacturer: 02/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• 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: 56 YR
• Patient Sex: Male