MAUDE Adverse Event Report: NEODENT - JJGC S.A. TI TITAMAX IMPLANT (5.0)4.5X9; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.327
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/27/2017
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
(b)(4) - the dentist reported that, 5 months after the dental implant was installed in intraoral region #19; its non-osseointegration was observed.A 40 ncm of primary stability was achieved.The patient presented insufficient bone quality/quantity (bone type iii) and bone graft was executed.

• Brand Name: TI TITAMAX IMPLANT (5.0)4.5X9
• 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: 7105981
• Report Number: 3008261720-2017-06698
• Device Sequence Number: 685720
• Product Code: DZE
• UDI-Device Identifier: 07898237567129
• UDI-Public: 07898237567129
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 12/11/2017
• Report Date (Section F): 11/14/2017

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: 08/19/2021
• Device Catalogue Number: 109.327
• Device Lot Number: 66940
• Other Device ID Number: 07898237567129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2017
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 11/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/11/2017
• 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: 55 YR
• Patient Weight: 80