MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY IMPLANT 14.0; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.739
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Failure of Implant (1924); Swelling (2091); Tissue Damage (2104)
Date of Event	09/11/2018
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 almost a month after the dental implant and temporary crown/abutment were placed in ada site 10 in the mouth, the implant did not integrate in type iii bone.Clinician reports patient's poor bone quality/qty, tongue pressure, biomechanical overload and mobility.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.The dentist reported that immediate load procedure was performed.
Event or Problem Description
The clinician reported that almost a month after the dental implant and temporary crown/abutment were placed in ada site 10 in the mouth, the implant did not integrate in type iii bone.Clinician reports patient's poor bone quality/qty, tongue pressure, biomechanical overload and mobility.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.(b)(4).

• Brand Name: FACILITY IMPLANT 14.0
• 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: 7953872
• Report Number: 3008261720-2018-05003
• Device Sequence Number: 16441660
• Product Code: DZE
• UDI-Device Identifier: 07898237569529
• UDI-Public: 07898237569529
• 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): 10/10/2018
• Report Date (Section F): 10/03/2018

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: 03/14/2019
• Device Catalogue Number: 109.739
• Device Lot Number: 800119877
• 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: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/10/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABUTMENT AND TEMPORARY CROWN PLACEMENT; ABUTMENT AND TEMPORARY CROWN PLACEMENT; ABUTMENT AND TEMPORARY CROWN PLACEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR