MAUDE Adverse Event Report: NEODENT JJGC S.A. CM DRIVE IMPLANT 5.0X16; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.687
Medical Device Problem Codes	Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/07/2017
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 five months after the dental implant was placed, in intraoral site #6 of the patient¿s mouth, non- osseointegration was observed.Peri-implantitis and mobility was reported.Immediate load was performed.The device will be forwarded to the manufacturer for investigation.There were no reported post- operative patient 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 is different from the item reported.Therefore, the lot number was not considered.After the evaluation, the event was considered as osseointegration failure.
Event or Problem Description
The clinician reported that five months after the dental implant was placed, in intraoral site #6 of the patient¿s mouth, non- osseointegration was observed.Peri-implantitis and mobility was reported.Immediate load was performed.The device will be forwarded to the manufacturer for investigation.There were no reported post- operative patient complications.(b)(4).

• Brand Name: CM DRIVE IMPLANT 5.0X16
• 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: 7123150
• Report Number: 3008261720-2017-06762
• Device Sequence Number: 13805547
• Product Code: DZE
• UDI-Device Identifier: 07899878023388
• UDI-Public: 07899878023388
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2017
• Report Date (Section F): 11/20/2017

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 Catalogue Number: 109.687
• Other Device ID Number: 07898237569253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2018
• Event Location: Other
• Date Report to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 05/03/2018
• 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: 54 YR