MAUDE Adverse Event Report: NEODENT - JJGC S.A. EXTERNAL HEX ZYGOMATIC IMPLANT 47.5 MM; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.461
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number reported by the dentist was not verified by the crm system, so it was not considered.The information provided in this report was based on information given by the dentist in neodent¿s products warranty form that was recorded in the system and is used by both the manufacturer and the subsidiary.The original complaint and the product were received by the subsidiary and did not arrive in the manufacturer yet.When this happens, a new evaluation of the complaint will be carried out and, if necessary, a new follow-up report will be send.
Event or Problem Description
(b)(4) - the dentist reported that 8 months and 6 days after the dental implant was installed in intraoral region 12#, its loss of osseointegration was observed.Moreover, 60n.Cm of primary stability was achieved, the patient presented bone type ii and bone graft was placed.
Additional Manufacturer Narrative
Lot number was not provided by customer.Considering the surgical methodology, it was seen that the dentist has used sequence of drills different than the one recommended for the implant installation.The investigation of the complaint was carried out considering the analysis of the information given by the dentist in the guarantee form and visual conference of the product returned by the dentist.
Event or Problem Description
(b)(4)- the dentist reported that 8 months and 6 days after the dental implant was installed in intraoral region 12#, its loss of osseointegration was observed.Moreover, 60n.Cm of primary stability was achieved, the patient presented bone type ii and bone graft was placed.

• Brand Name: EXTERNAL HEX ZYGOMATIC IMPLANT 47.5 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: 8977274
• Report Number: 3008261720-2019-04611
• Device Sequence Number: 10818191
• Product Code: DZE
• UDI-Device Identifier: 07898237567341
• UDI-Public: 07898237567341
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019
• Report Date (Section F): 08/15/2019

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 Model Number: 109.461
• Device Catalogue Number: 109.461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2020
• Event Location: Other
• Date Report to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 02/14/2020
• 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: 78 YR