MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPLANT 3.5X17; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.665
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
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 20 in the mouth, primary stability was not achieved in type ii bone.The implant was removed and another was placed in ada site 19.The site was not grafted.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.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.
Event or Problem Description
The clinician reported that on the day the implant was placed in ada site 20 in the mouth, primary stability was not achieved in type ii bone.The implant was removed and another was placed in ada site 19.The site was not grafted.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.(b)(4).

• Brand Name: CM TITAMAX EX ACQUA IMPLANT 3.5X17
• 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: 7933805
• Report Number: 3008261720-2018-04863
• Device Sequence Number: 1499906
• Product Code: DZE
• UDI-Device Identifier: 07899878016779
• UDI-Public: 07899878016779
• 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: 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): 10/04/2018
• Report Date (Section F): 09/19/2018

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: 03/21/2019
• Device Catalogue Number: 140.665
• Device Lot Number: 800237369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/14/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 12/14/2018
• 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