MAUDE Adverse Event Report: JJGC S.A. TAPERED IMPLANT IF 5.0X10 SP; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	CD0902020
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Fibrosis (3167)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2024 in the patient's mouth.On (b)(6) 2024, non-osseointegration was verified.Patient presented with bone type iii and fair oral hygiene.No product was returned to the manufacturer.At the event the patient experienced: pain, mobility, bleeding 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) 2024 in the patient's mouth.On (b)(6) 2024, non-osseointegration was verified.Patient presented with bone type iii and fair oral hygiene.No product was returned to the manufacturer.At the event, the patient experienced: pain, mobility, bleeding and inflammation.No further patient complications were reported.

• Brand Name: TAPERED IMPLANT IF 5.0X10 SP
• 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: 19512259
• Report Number: 0001222315-2024-001562
• Device Sequence Number: 19687681
• Product Code: DZE
• UDI-Device Identifier: 07899878038429
• UDI-Public: 07899878038429
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K193234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024
• Report Date (Section F): 05/16/2024

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: CD0902020
• Device Lot Number: JEW99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/17/2024
• Device Age: 29 MO
• Event Location: Other
• Date Report to Manufacturer: 05/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Sex: Male