MAUDE Adverse Event Report: NEODENT JJGC S.A. CM TITAMAX EX IMPL TI 4.0 X 17; ENDOSSEOUS DENTAL IPLANT

Catalog Number	109.640
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/20/2017
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 reported that 16 months after the dental implant was placed, in intraoral site 7 of the patient¿s mouth, bone loss was observed around the implant.Initial primary stability was achieved and immediate load was performed.Patient presented bone type ii.Patient did experience pain.The device will be forwarded to the manufacturer for investigation.There were no reported patient complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.Considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.
Event or Problem Description
The clinician reported that 16 months after the dental implant was placed, in intraoral site 7 of the patient¿s mouth, bone loss was observed around the implant.Initial primary stability was achieved and immediate load was performed.Patient presented bone type ii.Patient did experience pain.The device will be forwarded to the manufacturer for investigation.There were no reported patient complications.

• Brand Name: CM TITAMAX EX IMPL TI 4.0 X 17
• Common Device Name: ENDOSSEOUS DENTAL IPLANT
• Manufacturer (Section D): NEODENT JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 7223841
• Report Number: 3008261720-2018-00316
• Device Sequence Number: 13663215
• Product Code: DZE
• UDI-Device Identifier: 07898237568881
• UDI-Public: 07898237568881
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2018
• Report Date (Section F): 12/28/2017

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: Dentist
• Device Expiration Date: 10/19/2019
• Device Catalogue Number: 109.640
• Device Lot Number: 800157475
• Other Device ID Number: 07898237568881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/29/2018
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 12/28/2017
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 01/27/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR