MAUDE Adverse Event Report: JJGC S.A. CM DRIVE IMPLANT, TITANIUM, 3.5X13 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.995
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 10.Details of surgery: immediate extraction site.On (b)(6) 2020, non-osseointegration was verified.The device was forwarded to the manufacturer.There were no reported patient injuries or complications.

• Brand Name: CM DRIVE IMPLANT, TITANIUM, 3.5X13 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: 10698678
• Report Number: 0001222315-2020-12351
• Device Sequence Number: 3777727
• Product Code: DZE
• UDI-Device Identifier: 07899878023340
• UDI-Public: 07899878023340
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/19/2020
• Report Date (Section F): 09/23/2020

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: 09/09/2024
• Device Model Number: 109.995
• Device Catalogue Number: 109.995
• Device Lot Number: YL738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/19/2020
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 09/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/19/2020
• 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: 56 YR