MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM TITAMAX IMPLANT 3.5X15 MM; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.618
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Tissue Damage (2104)
Date of Event	12/17/2018
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 less drills than recommended to perform the implant installation.
Event or Problem Description
(b)(4).The dentist reported that after the dental implant was installed in intraoral region 23#, its non-osseointegration was observed.Moreover, 10n.Cm of primary stability was achieved, the patient presented insufficient bone quality/quantity (bone type ii), bone graft was performed, immediate load was done, fenestration and biomechanic overload has occurred.

• Brand Name: CM TITAMAX IMPLANT 3.5X15 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: 8278735
• Report Number: 3008261720-2019-00435
• Device Sequence Number: 1500350
• Product Code: DZE
• UDI-Device Identifier: 07898237568706
• UDI-Public: 07898237568706
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101945
• 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): 01/25/2019
• Report Date (Section F): 01/16/2019

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: 02/03/2022
• Device Catalogue Number: 109.618
• Device Lot Number: 94809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2019
• Device Age: 22 MO
• Event Location: Other
• Date Report to Manufacturer: 01/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/25/2019
• 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: 59 YR
• Patient Weight: 75