MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI DRIVE ACQUA IMPLANT (3.3) 3.5X11.5; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	140.754
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.Instradent usa, inc is submitting the report on behalf of neodent - jjgc.
Event or Problem Description
Rp 011637- the dentist reported that after 3 months dental implant was installed in intraoral region 8#, it had to be removed because the dentist was not able to remove only the abutment, which was stuck into the implant.In addition, 50ncm of primary stability was achieved, immediate implant was performed and the patient presented bone type ii.

• Brand Name: TI DRIVE ACQUA IMPLANT (3.3) 3.5X11.5
• 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: 7483142
• Report Number: 3008261720-2018-02002
• Device Sequence Number: 1716163
• Product Code: DZE
• UDI-Device Identifier: 07899878017097
• UDI-Public: 07899878017097
• 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: 2017
• 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): 05/03/2018
• Report Date (Section F): 04/13/2018

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: Dentist
• Device Expiration Date: 08/12/2019
• Device Catalogue Number: 140.754
• Device Lot Number: 800313995I
• Other Device ID Number: 07899878017097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2018
• Device Age: 7 MO
• Event Location: Other
• Date Report to Manufacturer: 04/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/03/2018
• 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 Weight: 85