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

Catalog Number	140.897
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	03/02/2017
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 4 months after the dental implant was placed in ada site #4 of patient's mouth, non-osseointegration was observed.It was reported that at time of the event, the patient presented with pain and mobility.The patient presented with type ii bone quality and the hygiene around the implant was reported to be good.It was reported that the implant was covered with bone and primary stability had been achieved.A profile drill was reported to have been used and the site was.

• Brand Name: CM DRIVE ACQUA IMPLANT, TITANIUM, 4.3X18
• Common Device Name: ENDOSEOUSS 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: 7029065
• Report Number: 3008261720-2017-04878
• Device Sequence Number: 1006225
• 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: 04/14/2017
• Device Catalogue Number: 140.897
• Device Lot Number: 800186879I
• 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: 08/10/2017
• 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, 3 OTHER IMPLANTS, ONE PROSTHESIS; ABUTMENT 115.211, 3 OTHER IMPLANTS, ONE PROSTHESIS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR