MAUDE Adverse Event Report: JJGC S.A. TITAMAX IMPL TI (4.1)4.0X11; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch number could not be verified due to incomplete or missing information and / or product from the customer.Our manufacturing q-system assures that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.The removal of a dental implant during surgery without the replacement of another dental implant is a known inherent risk of the procedure due to either lack of primary stability of the implant (patienor procedure related).It may also include the removal of an implant after osseointegration due to either the clinician's or patient¿s decision.The manufacturer¿s trend analysis confirms that usually procedural errors and/or patient's condition contribute to the event.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2018 in the patient's mouth.Details of surgery: immediate extraction site.On (b)(6) 2024, the implant was removed upon patient¿s request.The device was forwarded to the manufacturer.At the event the patient experienced: peri-implantitis, pain, swelling and fistula.No further patient complications were reported.

• Brand Name: TITAMAX IMPL TI (4.1)4.0X11
• 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
• Manufacturer (Section G): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 20812260
• Report Number: 3008261720-2024-003786
• Device Sequence Number: 13109502
• Product Code: DZE
• UDI-Device Identifier: 07898237567006
• UDI-Public: 07898237567006
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/29/2024

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 Catalogue Number: 109.303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/29/2024
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2024
• 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 Sex: Male