MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX IMPLANT WITH MOUNT 3.3X13; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109142
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Damage (2104)
Date of Event	02/04/2016
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 9 months after the dental implant was installed in intraoral region #8, it was verified its loss of osseointegration.Thirty ncm of primary stability was achieved and immediate load was not performed.The patient presented insufficient bone quality/ quantity (bone type iii) and fenestration occurred during surgery.

• Brand Name: TITAMAX IMPLANT WITH MOUNT 3.3X13
• 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: 7018557
• Report Number: 3008261720-2017-02050
• Device Sequence Number: 1496142
• Product Code: DZE
• UDI-Device Identifier: 07898237566672
• UDI-Public: 07898237566672
• 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: 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): 06/20/2016
• Report Date (Section F): 06/20/2016

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: 11/29/2019
• Device Catalogue Number: 109142
• Device Lot Number: 800038160
• Other Device ID Number: 07898237566672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/10/2017
• Event Location: Other
• Date Report to Manufacturer: 06/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 11/10/2017
• 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: 32 YR
• Patient Weight: 72