MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX IMPLANT 4.0X19; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.641
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/02/2016
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
(b)(4).The dentist reported that, 1 year and 5 months after the dental implant was installed in intraoral region #4; its non- osseointegration was observed.Bone graft was executed.

• Brand Name: CM TITAMAX EX IMPLANT 4.0X19
• 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: 7036555
• Report Number: 3008261720-2017-06247
• Device Sequence Number: 16378613
• Product Code: DZE
• UDI-Device Identifier: 07898237568898
• UDI-Public: 07898237568898
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/16/2017
• Report Date (Section F): 10/04/2017

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: Dentist
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 109.641
• Device Lot Number: 800124384
• Other Device ID Number: 07898237568898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2017
• Device Age: 29 MO
• Event Location: Other
• Date Report to Manufacturer: 10/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 11/16/2017
• 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: 49 YR