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

Model Number	109.296
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Tissue Damage (2104)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Considering the surgical methodology, it was seen that the dentist made immediate load without a good primary stability achieved.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 1 month after the dental implant was installed in intraoral region 3#, its non-osseointegration was observed.Moreover, the patient presented insufficient bone quality/quantity (bone type ii), immediate implant was performed and fenestration has occurred.
Additional Manufacturer Narrative
The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (analainen et al.2009).Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al.2008).Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: 1.Absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia 2.Absence of a recurrent peri-implant infection with suppuration 3.Absence of implant mobility 4.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in fdi 16.Details of surgery: primary stability not achieved, implant surface not completely covered with bone and immediate extraction site.On (b)(6) 2020, non-osseointegration was verified.Patient presented with inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain and swelling.No further patient complications were reported.

• Brand Name: TITAMAX IMPL TI 5.0X11
• 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: 10025624
• Report Number: 3008261720-2020-02020
• Device Sequence Number: 16847403
• Product Code: DZE
• UDI-Device Identifier: 07898237566962
• UDI-Public: 07898237566962
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020
• Report Date (Section F): 04/13/2020

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: 03/28/2024
• Device Model Number: 109.296
• Device Catalogue Number: 109.296
• Device Lot Number: WC152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/22/2020
• Device Age: 11 MO
• Event Location: Other
• Date Report to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/22/2020
• 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