MAUDE Adverse Event Report: JJGC S.A. CM Alvim Impl Ti 4.3X11.5; Endosseous Dental Implant

Catalog Number	109.649
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Fibrosis (3167)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury

• Brand Name: CM Alvim Impl Ti 4.3X11.5
• 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 ; +1(978)747-2509
• MDR Report Key: 50827832
• Report Number: 3008261720-2026-005105
• Device Sequence Number: 10676966
• Product Code: DZE
• UDI-Device Identifier: 07898237568973
• UDI-Public: 07898237568973
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101945
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• 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): 09/18/2026

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: 02/18/2025
• Device Catalogue Number: 109.649
• Device Lot Number: ANF22
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• 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: 61 YR
• Patient Sex: Male