MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX EX ACQUA IMPLANT 3.5X15; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.664
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Date of Event	08/19/2017
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 2 months after the dental implant was installed in intraoral region 11, its non-osseointegration was observed.32 ncm of primary stability was achieved and the implant was installed without immediately load.The patient presented bone type iv.

• Brand Name: CM TITAMAX EX ACQUA IMPLANT 3.5X15
• 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: 7235285
• Report Number: 3008261720-2018-00419
• Device Sequence Number: 140159
• Product Code: DZE
• UDI-Device Identifier: 07899878016762
• UDI-Public: 07899878016762
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/01/2018
• Report Date (Section F): 01/11/2018

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: Dentist
• Device Expiration Date: 08/09/2016
• Device Catalogue Number: 140.664
• Device Lot Number: 800145832
• Other Device ID Number: 07899878016762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2018
• Device Age: 36 MO
• Event Location: Other
• Date Report to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 02/01/2018
• 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
• Patient Age: 53 YR