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 Code	Tissue Damage (2104)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.The information provided in this report was based on information given by the dentist in neodent¿s products warranty form that was recorded in the system that is used by both the manufacturer and the subsidiary.The original complaint and the product were received by the subsidiary and did not arrive in the manufacturer yet.When this happens, a new evaluation of the complaint will be carried out and, if necessary, a follow-up report will be send.Considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.
Event or Problem Description
(b)(4) - the dentist reported that, after the dental implant was installed in intraoral region #6, its non-osseointegration was observed.The patient presented bone type ii.
Additional Manufacturer Narrative
The complaint was received by manufacturer and, after analysis, new informations were obtained.A follow-up is being sent to correct these informations according to the evaluation made.Considering the surgical methodology, it was seen that the dentist has selected an implant design which is not recommended for the patient's bone quality.Moreover, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form, visual conference of the product returned by the dentist and the evaluation of relevant production records.
Event or Problem Description
(b)(4).The dentist reported that, after the dental implant was installed in intraoral region #6, its non-osseointegration was observed.The patient presented bone type ii.

• 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: 8794948
• Report Number: 3008261720-2019-03652
• Device Sequence Number: 2638974
• Product Code: DZE
• UDI-Device Identifier: 07899878016762
• UDI-Public: 07899878016762
• Combination Product (Y/N): N
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019
• Report Date (Section F): 06/21/2019

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: 01/21/2019
• Device Catalogue Number: 140.664
• Device Lot Number: 91100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2019
• Device Age: 25 MO
• Event Location: Other
• Date Report to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 10/27/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: 39 YR