MAUDE Adverse Event Report: JJGC S.A. CM TITAMAX EX ACQUA IMPL TI 3.75X15; ENDOSSEOUS DENTAL IMPLANT

Model Number	140.669
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Numbness (2415); Fibrosis (3167)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2017 in ada 4.Details of surgery: implant surface not completely covered with bone.On (b)(6) 2022, fracture of the implant was verified.Patient presented with bone type iii, fair oral hygiene and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: mobility, bleeding, hypersensitivity and numbness.No further patient complications were reported.

• Brand Name: CM TITAMAX EX ACQUA IMPL TI 3.75X15
• 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: 15907909
• Report Number: 0001222315-2022-026482
• Device Sequence Number: 17586310
• Product Code: DZE
• UDI-Device Identifier: 07899878016816
• UDI-Public: 07899878016816
• 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: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/02/2022
• Report Date (Section F): 11/08/2022

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: 03/21/2017
• Device Model Number: 140.669
• Device Catalogue Number: 140.669
• Device Lot Number: 800180936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2022
• Device Age: 127 MO
• Event Location: Other
• Date Report to Manufacturer: 11/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2022
• 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: 58 YR
• Patient Sex: Female