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 Codes	Unspecified Infection (1930); Swelling (2091); Tissue Damage (2104)
Date of Event	07/10/2018
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 used sequence of drills different than the one recommended for the implant installation.
Event or Problem Description
(b)(4) ¿ the dentist reported that after dental implant was installed in intraoral region 29#, its non-osseointegration was observed.In addition, 45ncm of primary stability was achieved.

• 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: 7936207
• Report Number: 3008261720-2018-04899
• Device Sequence Number: 1513904
• 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): 10/04/2018
• Report Date (Section F): 09/14/2018

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: Health Professional
• Device Expiration Date: 10/13/2017
• Device Catalogue Number: 140.752
• Device Lot Number: 17771I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2018
• Device Age: 33 MO
• Event Location: Other
• Date Report to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/04/2018
• 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: 54 YR
• Patient Weight: 87