MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPLANT 3.5X17; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.665
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/03/2016
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 nearly six months after the dental implant was placed, in ada site #13 of the patient¿s mouth, non-osseointegration was observed.The patient presented with type iii bone.The device will be forwarded to the manufacturer for investigation.There were no reported patient injuries or complications.
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 nearly six months after the dental implant was placed, in ada site #13 of the patient¿s mouth, non-osseointegration was observed.The patient presented with type iii bone.There were no reported patient injuries or complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.After the evaluation was noticed that the item received is different from the item reported.This follow up corrects that information.In telephone contact, the complainant informed that the information about lot number of the product was not available.
Event or Problem Description
(b)(4).The clinician reported that nearly six months after the dental implant was placed, in ada site #13 of the patient¿s mouth, non-osseointegration was observed.The patient presented with type iii bone.There were no reported patient injuries or complications.

• Brand Name: CM TITAMAX EX ACQUA IMPLANT 3.5X17
• 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: 7029681
• Report Number: 3008261720-2017-04970
• Device Sequence Number: 16397217
• Product Code: DZE
• UDI-Device Identifier: 07899878016823
• UDI-Public: 07899878016823
• 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: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2018
• Report Date (Section F): 11/03/2016

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: Health Professional
• Device Catalogue Number: 140.665
• Other Device ID Number: 07899878016823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/28/2018
• Event Location: Other
• Date Report to Manufacturer: 11/03/2016
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: 11/21/2017; 11/21/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 01/18/2018; 09/28/2018
• 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