MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX IMPLANT WITH MOUNT 3.3X11 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.141
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/20/2018
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 5 years and 2 months after dental implant was installed in intraoral region 4#, its fracture occurred.In addition, 20 ncm of primary stability was achieved, the patient presented bone type iii and biomechanical overload has happened.

• Brand Name: TITAMAX IMPLANT WITH MOUNT 3.3X11 MM
• 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: 7829756
• Report Number: 3008261720-2018-03908
• Device Sequence Number: 2348219
• Product Code: DZE
• UDI-Device Identifier: 07898237566665
• UDI-Public: 07898237566665
• 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: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/29/2018
• Report Date (Section F): 07/23/2018

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 Expiration Date: 04/25/2017
• Device Catalogue Number: 109.141
• Device Lot Number: 800053458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2018
• Device Age: 69 MO
• Event Location: Other
• Date Report to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 08/29/2018
• 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: 62 YR
• Patient Weight: 90