MAUDE Adverse Event Report: JJGC S.A. GM HELIX IMPLANT,TI,5.0X10; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.954
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	04/24/2025
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) 2025, loss of osseointegration was verified.Patient presented with bone type iii.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
The batch number could be verified.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 loss of an endosseous dental implant after successful osseointegration and restoration is a known inherent risk of the procedure.Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: 1.Absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia, 2.Absence of a recurrent peri-implant infection with suppuration, 3.Absence of implant mobility, 4.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.

• Brand Name: GM HELIX IMPLANT,TI,5.0X10
• 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: 22256570
• Report Number: 3008261720-2025-001678
• Device Sequence Number: 7794462
• Product Code: DZE
• UDI-Device Identifier: 07899878024255
• UDI-Public: 07899878024255
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K163194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 05/19/2025

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: 109.954
• Device Lot Number: CYCL3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2025
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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