MAUDE Adverse Event Report: JJGC S.A. CM TITAMAX IMPL TI 4.0X15; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.634
Medical Device Problem Codes	Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Fibrosis (3167)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports that the day the implant was placed in ada 9, failure occurred upon insertion.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: infection, mobility and inflammation.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 28.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii.The device was forwarded to the manufacturer.At the event the patient experienced: infection, mobility and inflammation.No further patient complications were reported.

• Brand Name: CM TITAMAX IMPL TI 4.0X15
• 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: 11260277
• Report Number: 0001222315-2021-01589
• Device Sequence Number: 2555592
• Product Code: DZE
• UDI-Device Identifier: 07898237568829
• UDI-Public: 07898237568829
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101945
• 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
• Report Date (Section B): 05/16/2022
• Report Date (Section F): 01/07/2021

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: 11/18/2019
• Device Model Number: 109.634
• Device Catalogue Number: 109.634
• Device Lot Number: 800159554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2022
• Device Age: 67 MO
• Event Location: Other
• Date Report to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/16/2022
• 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