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

Catalog Number	109.998
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Missing lot information and placement/removal dates were requested from the initial reporter.A follow up report will be submitted when the information becomes available.The best estimate of the date of event was provided.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported the immediate dental implant placed in ada site 5 in the mouth did not achieve osseointegration in type iv bone.The implant was torqued manually to 40 ncm.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.
Additional Manufacturer Narrative
Missing lot information and placement/removal dates were requested from the initial reporter.A follow up report will be submitted when the information becomes available.The best estimate of the date of event was provided.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported the immediate dental implant placed in ada site 5 in the mouth did not achieve osseointegration in type iv bone.The implant was torqued manually to 40 ncm.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.
Additional Manufacturer Narrative
Missing lot information and placement/removal dates were requested from the initial reporter.A follow up report will be submitted when the information becomes available.The best estimate of the date of event was provided.Exemption number: e2015015.Lot number was not provided by customer.Considering the surgical methodology, it was seen that the dentist has used less drills than recommended to perform the implant installation.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 the immediate dental implant placed in ada site 5 in the mouth did not achieve osseointegration in type iv bone.The implant was torqued manually to 40 ncm.The product will be forwarded to the manufacturer for investigation.There were no reported patient 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: 8192216
• Report Number: 3008261720-2018-06043
• Device Sequence Number: 11292257
• Product Code: DZE
• UDI-Device Identifier: 07899878023371
• UDI-Public: 07899878023371
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2019
• Report Date (Section F): 12/14/2018

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 Catalogue Number: 109.998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2019
• Event Location: Other
• Date Report to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 12/14/2018; 04/17/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/11/2019; 05/07/2019
• 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