MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX IMPLANT (5.0)4.5X11; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.328
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.After the evaluation was noticed that the lot number reported is not from the item received.Therefore, the lot number was not considered.
Event or Problem Description
(b)(4) - the dentist reported that after 6 years and 8 months dental implant was installed in intraoral region 30#, its loss of osseointegration was observed.In addition, 40ncm of primary stability was achieved and the patient presented bone type iii.

• Brand Name: TI TITAMAX IMPLANT (5.0)4.5X11
• 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: 7525395
• Report Number: 3008261720-2018-02272
• Device Sequence Number: 19178785
• Product Code: DZE
• UDI-Device Identifier: 07898237567136
• UDI-Public: 07898237567136
• 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: 2010
• 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): 05/18/2018
• Report Date (Section F): 04/27/2018

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 Catalogue Number: 109.328
• Other Device ID Number: 07898237567136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2018
• Event Location: Other
• Date Report to Manufacturer: 04/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/18/2018
• 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: 49 YR
• Patient Weight: 100