MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX EX IMPLANT (4.1)4.0X19; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.593
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/11/2017
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, 8 months after the dental implant was installed in intraoral region #10, its non-osseointegration was observed.Twentyfive ncm of primary stability was achieved and the implant was installed without immediately load.The patient presented bone type iii, fenestration occurred during surgery and bone graft was executed.

• Brand Name: TI TITAMAX EX IMPLANT (4.1)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: 7041530
• Report Number: 3008261720-2017-06549
• Device Sequence Number: 16483384
• Product Code: DZE
• UDI-Device Identifier: 07898237568454
• UDI-Public: 07898237568454
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101207
• 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): 11/17/2017
• Report Date (Section F): 10/27/2017

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: 09/19/2016
• Device Catalogue Number: 109.593
• Device Lot Number: 800103073
• Other Device ID Number: 07898237568454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2017
• Device Age: 72 MO
• Event Location: Other
• Date Report to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/17/2017
• 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: 58 YR