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 Codes	Pain (1994); Fibrosis (3167)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 10.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
Additional Manufacturer Narrative
Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 10.Details of surgery: sinus augmentation.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
Additional Manufacturer Narrative
Non-fatal serious injury or device malfunction stored due to covid 19 pandemic in accordance with fda guidance "postmarketing adverse event reporting for medical products and dietary supplements during a pandemic" published may 2020.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 10.Details of surgery: sinus augmentation.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bruxism.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.

• 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: 10698511
• Report Number: 0001222315-2020-12247
• Device Sequence Number: 19570679
• Product Code: DZE
• UDI-Device Identifier: 07899878023340
• UDI-Public: 07899878023340
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 03/04/2022
• 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: 03/18/2024
• Device Model Number: 109.995
• Device Catalogue Number: 109.995
• Device Lot Number: VY127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2022
• Device Age: 17 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
• Supplement Date Received by Manufacturer: 09/23/2020; 09/23/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 03/07/2022; 03/08/2022
• 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: 79 YR
• Patient Sex: Male