MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX IMPL TI 3.75X17; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.670
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reports 9 months after the dental implant and denture were placed in ada site 20 in the mouth, the implant had not achieved integration in type iii bone.Clinician reports an infection and dehiscence.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.After the evaluation, the event was considered as loss of osseointegration.
Event or Problem Description
The clinician reports 9 months after the dental implant and denture were placed in ada site 20 in the mouth, the implant had not achieved integration in type iii bone.Clinician reports an infection and dehiscence.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.(b)(4).

• Brand Name: CM TITAMAX EX IMPL TI 3.75X17
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 7830355
• Report Number: 3008261720-2018-03940
• Device Sequence Number: 1175355
• Product Code: DZE
• UDI-Device Identifier: 07898237569178
• UDI-Public: 07898237569178
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018
• Report Date (Section F): 07/18/2018

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: 06/13/2019
• Device Catalogue Number: 109.670
• Device Lot Number: 800137696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2018
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTURE PLACEMENT; DENTURE PLACEMENT
• Outcome Attributed to Adverse Event: Required Intervention