MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE ACQUA IMPLANT 5.0X11.5; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.691
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The placement/removal dates of the implant were requested from the initial reporter.The best estimate of the date of event was provided.A follow up report will be submitted when the information becomes available.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported that after the dental implant was placed in ada site 5 in the mouth, the implant failed in type i bone.The implant was torqued manually to 50 ncm.The product 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 11 months after the dental implant was placed in ada site 2 in the mouth, the implant lost osseointegration in type i bone.The implant was torqued manually to 50 ncm.The product 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 after the evaluation was noticed that the item received is different from the item reported.Therefore, the item was corrected and the lot number was not considered.Moreover, 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 investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and visual conference of the product returned by the dentist.
Event or Problem Description
The clinician reported that 11 months after the dental implant was placed in ada site 2 in the mouth, the implant lost osseointegration in type i bone.The implant was torqued manually to 50 ncm.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.Rp.017748.

• Brand Name: CM DRIVE ACQUA IMPLANT 5.0X11.5
• 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: 8250655
• Report Number: 3008261720-2019-00271
• Device Sequence Number: 16542594
• Product Code: DZE
• UDI-Device Identifier: 07899878016571
• UDI-Public: 07899878016571
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2019
• Report Date (Section F): 01/11/2019

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: 02/01/2019
• Device Catalogue Number: 140.691
• Device Lot Number: 91091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2019
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/07/2019; 03/25/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/08/2019; 04/11/2019
• 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