MAUDE Adverse Event Report: NEODENT JJGC S.A. CM DRIVE ACQUA IMPLANT, TITANIUM, 5.0X18; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.898
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/30/2017
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 on the date of placement in ada site 25, a failure occurred upon insertion.Primary stability was not obtained.Patient presented with type ii bone.Insufficient bone quality was noted and a bone graft was placed.The implant will be forwarded to the manufacturer for investigation.There were no reported patient injuries or post-operative 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 on the date of placement in ada site 25, a failure occurred upon insertion.Primary stability was not obtained.Patient presented with type ii bone.Insufficient bone quality was noted and a bone graft was placed.The implant will be forwarded to the manufacturer for investigation.There were no reported patient injuries or post-operative complications.

• Brand Name: CM DRIVE ACQUA IMPLANT, TITANIUM, 5.0X18
• 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: 7030118
• Report Number: 3008261720-2017-05273
• Device Sequence Number: 19086020
• Product Code: DZE
• UDI-Device Identifier: 07899878018087
• UDI-Public: 07899878018087
• 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: Dentist
• 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: 09/06/2018
• Device Catalogue Number: 140.898
• Device Lot Number: 66852I
• Other Device ID Number: 07899878018087
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• 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: 50 YR