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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/24/2017
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 the implant was placed and removed on the same day in ada site 13 as no torque was noted and primary stability was not achieved.Another implant was not placed after removal on that day.The patient's bone quality was reported to be type ii.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.
Event or Problem Description
The clinician reported that the implant was placed and removed on the same day in ada site 13 as no torque was noted and primary stability was not achieved.Another implant was not placed after removal on that day.The patient's bone quality was reported to be type ii.The device will be forwarded to the manufacturer for investigation.There were no reported patient complications.

• 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: 7030079
• Report Number: 3008261720-2017-05214
• Device Sequence Number: 1549396
• Product Code: DZE
• UDI-Device Identifier: 07899878018070
• UDI-Public: 07899878018070
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Dental Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2017
• Report Date (Section F): 09/11/2017

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: 10/21/2018
• Device Catalogue Number: 140.897
• Device Lot Number: 79894I
• Other Device ID Number: 07899878018070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2018
• Event Location: Other
• Date Report to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 02/28/2018
• 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
• Patient Age: 60 YR