MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT 5.0X13; ABUTMENT PLACEMENT

Catalog Number	140.686
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was sent to the manufacturer in a manner unsuitable for investigation.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported that over 1 month after the immediate dental implant was placed in ada site 4 in the patient's mouth, the implant did not achieve osseointegration in type ii bone.The clinician noted the patient's bruxism.The implant was torqued manually to 45 ncm.There were no reported patient complications.
Additional Manufacturer Narrative
The device was sent to the manufacturer in a manner unsuitable for investigation.Exemption number: e2015015.(b)(4).Considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.The information provided in this report was based on information given by the dentist in neodent¿s products warranty form that was recorded in the system that is used by both the manufacturer and the subsidiary.The original complaint and the product were received by the subsidiary and did not arrive in the manufacturer yet.When this happens, a new evaluation of the complaint will be carried out and, if necessary, a new follow-up report will be send.
Event or Problem Description
The clinician reported that over 1 month after the immediate dental implant was placed in ada site 4 in the patient's mouth, the implant did not achieve osseointegration in type ii bone.The clinician noted the patient's bruxism.The implant was torqued manually to 45 ncm.There were no reported patient complications.

• Brand Name: CM DRIVE ACQUA IMPLANT 5.0X13
• Common Device Name: ABUTMENT PLACEMENT
• Manufacturer (Section D): NEODENT - JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 8558229
• Report Number: 3008261720-2019-01782
• Device Sequence Number: 14026511
• Product Code: DZE
• UDI-Device Identifier: 07899878016878
• UDI-Public: 07899878016878
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019
• Report Date (Section F): 04/10/2019

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 Expiration Date: 10/03/2019
• Device Catalogue Number: 140.686
• Device Lot Number: 800322150I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2019
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/09/2019
• 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 PLACEMENT; ABUTMENT PLACEMENT
• Outcome Attributed to Adverse Event: Required Intervention