MAUDE Adverse Event Report: NEODENT - JJGC S.A. FACILITY ACQUA IMPLANT 12; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.738
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Missing lot information was requested from the initial reporter.A follow up report will be submitted should the information become available.Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
The clinician reported that 2.5 months after the dental implant and healing cap were placed in ada site 12 in the mouth, the implant did not achieve osseointegration in type ii bone.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Lot number was not provided by customer.
Event or Problem Description
The clinician reported that 2.5 months after the dental implant and healing cap were placed in ada site 12 in the mouth, the implant did not achieve osseointegration in type ii bone.The product will be forwarded to the manufacturer for investigation.There were no reported patient complications.(b)(4).

• Brand Name: FACILITY ACQUA IMPLANT 12
• 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: 8185456
• Report Number: 3008261720-2018-06001
• Device Sequence Number: 16830485
• Product Code: DZE
• UDI-Device Identifier: 07899878017042
• UDI-Public: 07899878017042
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150199
• 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): 12/20/2018
• Report Date (Section F): 12/11/2018

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 Catalogue Number: 140.738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2019
• Event Location: Other
• Date Report to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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: HEALING CAP PLACEMENT; HEALING CAP PLACEMENT; HEALING CAP PLACEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR