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 Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/19/2017
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 nearly 1 month after the dental implant in ada site 13 was placed, the implant lost osseointegration in type iii bone.No infection was present.A bone graft was completed after the implant removal.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.After the evaluation was noticed that the item received was not manufactured by neodent.
Event or Problem Description
The clinician reported that nearly 1 month after the dental implant in ada site 13 was placed, the implant lost osseointegration in type iii bone.No infection was present.A bone graft was completed after the implant removal.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative 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: 7162185
• Report Number: 3008261720-2018-00011
• Device Sequence Number: 1447624
• Product Code: DZE
• UDI-Device Identifier: 07899878018070
• UDI-Public: 07899878018070
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K150182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018
• Report Date (Section F): 12/07/2017

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: Health Professional
• Device Catalogue Number: 140.897
• Other Device ID Number: 07899878018070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2018
• Event Location: Other
• Date Report to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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, BONE GRAFT; ABUTMENT, BONE GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR