MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPL TI 3.75X15; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.669
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	09/13/2016
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 almost five months after the dental implant was placed, in ada site #13 of the patient¿s mouth, non-osseointegration was observed.The patient presented type ii bone.The device will be forwarded to the manufacturer for investigation.Patient reported pain, mobility and abscess at time of event, no further complications were observed.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
(b)(4) - the clinician reported that almost five months after the dental implant was placed, in ada site #13 of the patient¿s mouth, non-osseointegration was observed.The patient presented type ii bone.Patient reported pain, mobility and abscess at time of event, no further complications were observed.

• Brand Name: CM TITAMAX EX ACQUA IMPL TI 3.75X15
• 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: 7029699
• Report Number: 3008261720-2017-04968
• Device Sequence Number: 1109814
• Product Code: DZE
• UDI-Device Identifier: 07899878016816
• UDI-Public: 07899878016816
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017
• Report Date (Section F): 10/03/2016

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 Catalogue Number: 140.669
• Other Device ID Number: 07899878016816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2018
• Event Location: Other
• Date Report to Manufacturer: 10/03/2016
• Initial Date Received by Manufacturer: 10/03/2016
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 01/18/2018
• 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