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

Catalog Number	140.686
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was sent to the manufacturer in a manner unsuitable for investigation.Additional patient codes (f10): 2104, 2277.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported that almost 2 months after the dental implant was placed in ada site 11 in the mouth, the implant did not integrate.Clinician reported patient's diseased mucous membrane, peri-implantitis, sinus perforation, pain, mobility, bleeding and complications in the site prep.The site was grafted.There were no reported post-operative complications.
Event or Problem Description
The clinician reported that almost 2 months after the dental implant was placed in ada site 11 in the mouth, the implant did not integrate.Clinician reported patient's diseased mucous membrane, peri-implantitis, sinus perforation, pain, mobility, bleeding and complications in the site prep.The site was grafted.There were no reported post-operative complications.(b)(4).
Additional Manufacturer Narrative
Additional patient codes (f10): 2104, 2277.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.The device was not received by the manufacturer.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and the evaluation of relevant production records.

• Brand Name: CM DRIVE ACQUA IMPLANT 5.0X13
• 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: 8269147
• Report Number: 3008261720-2019-00333
• Device Sequence Number: 2082289
• Product Code: DZE
• UDI-Device Identifier: 07899878016878
• UDI-Public: 07899878016878
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019
• Report Date (Section F): 01/14/2019

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: 02/06/2019
• Device Catalogue Number: 140.686
• Device Lot Number: 94960I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2019
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: BONE GRAFT; BONE GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR