MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 5.0X13 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.998
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Tissue Damage (2104); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 30.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 30.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2019 in ada 30.Details of surgery: sinus augmentation.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• Brand Name: CM DRIVE IMPLANT, TITANIUM, 5.0X13 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: 10386165
• Report Number: 0001222315-2020-08835
• Device Sequence Number: 2004606
• Product Code: DZE
• UDI-Device Identifier: 07899878023371
• UDI-Public: 07899878023371
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2021
• Report Date (Section F): 05/11/2021

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: 02/21/2024
• Device Model Number: 109.998
• Device Catalogue Number: 109.998
• Device Lot Number: VM909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2021
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 05/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 05/11/2021
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 05/03/2021; 06/04/2021
• 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: 72 YR