MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT, TITANIUM, 4.3X18; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.897
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	06/27/2017
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 3 months after the dental implant was placed in ada site (b)(6)of patient's mouth, non-osseointegration was observed.It was reported that at time of the event, the patient presented with mobility.The patient presented with fair hygiene around the implant.It was reported that the implant was not covered with bone and primary stability had been achieved.A profile drill was reported to have been used and the site was tapped prior to the implant being manually placed.

• Brand Name: CM DRIVE ACQUA IMPLANT, TITANIUM, 4.3X18
• 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: 7029074
• Report Number: 3008261720-2017-04879
• Device Sequence Number: 13694653
• Product Code: DZE
• UDI-Device Identifier: 07899878018070
• UDI-Public: 07899878018070
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/14/2017
• Report Date (Section F): 08/10/2017

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: 04/29/2017
• Device Catalogue Number: 140.897
• Device Lot Number: 800188212I
• Other Device ID Number: 07899878018070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2017
• Device Age: 2 MO
• Event Location: Other
• Date Report to Manufacturer: 08/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2017
• Initial Report FDA Received Date: 11/14/2017
• 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: ABUTMENT 115.211; ABUTMENT 115.211
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR