MAUDE Adverse Event Report: NEODENT - JJGC S.A. TITAMAX SMART EX IMPLANT (4.1)4.0X11 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.781
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Tissue Damage (2104)
Date of Event	06/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 and 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 new follow-up report will be send.
Event or Problem Description
(b)(4)- the dentist reported that 7 months and 9 days after the dental implant was installed in intraoral region 30#, its fracture was observed.
Additional Manufacturer Narrative
Additional evaluation c.Conclusion: 18/failure to follow instructions additional evaluation c.Conclusion: 50/ device failure related to patient's cond.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.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.Considering the surgical methodology, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.
Event or Problem Description
(b)(4) - the dentist reported that 7 months and 9 days after the dental implant was installed in intraoral region 30#, its fracture was observed.

• Brand Name: TITAMAX SMART EX IMPLANT (4.1)4.0X11 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: 9161678
• Report Number: 3008261720-2019-05042
• Device Sequence Number: 13931378
• Product Code: DZE
• UDI-Device Identifier: 07898237569895
• UDI-Public: 07898237569895
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K133510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 10/07/2019
• Report Date (Section F): 09/10/2019

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: 10/29/2018
• Device Model Number: 109.781
• Device Catalogue Number: 109.781
• Device Lot Number: 800108144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2020
• Device Age: 68 MO
• Event Location: Other
• Date Report to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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: 57 YR