MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (3.3) 3.5X8 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.752
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.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 4 months and 3 days after the dental implant was installed in intraoral region 18#, its non- osseointegration was observed.Moreover, 20n.Cm of primary stability was achieved and the patient presented insufficient bone quality/quantity (bone type ii).

• Brand Name: TI DRIVE ACQUA IMPLANT (3.3) 3.5X8 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: 8407506
• Report Number: 3008261720-2019-01042
• Device Sequence Number: 11276260
• Product Code: DZE
• UDI-Device Identifier: 07899878017073
• UDI-Public: 07899878017073
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/11/2019
• Report Date (Section F): 02/12/2019

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: 08/12/2019
• Device Catalogue Number: 140.752
• Device Lot Number: 800313989I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2019
• Device Age: 16 MO
• Event Location: Other
• Date Report to Manufacturer: 02/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/11/2019
• 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: 52 YR