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	12/11/2017
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, 5-6 months after placement in site 19, the implant was removed.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, 5-6 months after placement in site 19, the implant was removed.The device will be forwarded to the manufacturer for investigation.There were no reported patient complications.(b)(4).

• 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: 7302372
• Report Number: 3008261720-2018-00971
• Device Sequence Number: 14048146
• Product Code: DZE
• UDI-Device Identifier: 07899878018070
• UDI-Public: 07899878018070
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: distributor,foreign
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018
• Report Date (Section F): 12/21/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/09/2018
• Event Location: Other
• Date Report to Manufacturer: 12/21/2017
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/09/2018
• 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: 70 YR