MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 3.5X8 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.1004
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Inflammation (1932); Hyperresponsive to stimuli (4538); Swelling/ Edema (4577)
Date of Event	01/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 30.On (b)(6) 2021, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: swelling, increased sensitivity and inflammation.No further patient complications were reported.

• Brand Name: CM DRIVE IMPLANT, TITANIUM, 3.5X8 MM
• 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: 12853934
• Report Number: 0001222315-2021-20413
• Device Sequence Number: 4081442
• Product Code: DZE
• UDI-Device Identifier: 07899878023432
• UDI-Public: 07899878023432
• 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: 2020
• 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): 11/22/2021
• Report Date (Section F): 10/28/2021

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: 01/16/2023
• Device Model Number: 109.1004
• Device Catalogue Number: 109.1004
• Device Lot Number: 800333882I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2021
• Device Age: 36 MO
• Event Location: Other
• Date Report to Manufacturer: 10/28/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2021
• 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: 62 YR
• Patient Sex: Male