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

Catalog Number	109.998
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Swelling (2091)
Date of Event	08/29/2018
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 on the day the implant was placed in ada site 11 in the mouth, primary stability was achieved, however, clinician noted patient's infection, mobility, bleeding and an abscess on that day.Another implant was not placed on the same day in site nor was the site grafted.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.
Event or Problem Description
The clinician reported that on the day the implant was placed in ada site 11 in the mouth, primary stability was achieved, however, clinician noted patient's infection, mobility, bleeding and an abscess on that day.Another implant was not placed on the same day in site nor was the site grafted.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.(b)(4).

• Brand Name: CM DRIVE 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: 7899663
• Report Number: 3008261720-2018-04741
• Device Sequence Number: 1806837
• Product Code: DZE
• UDI-Device Identifier: 07899878023371
• UDI-Public: 07899878023371
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• 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): 09/21/2018
• Report Date (Section F): 09/11/2018

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: 03/24/2022
• Device Catalogue Number: 109.998
• Device Lot Number: 800237352I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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: 60 YR