MAUDE Adverse Event Report: NEODENT - JJGC S.A. EXTERNAL HEX ZYGOMATIC IMPLANT 45.0; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.452
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
Event or Problem Description
The clinician reported that nearly 5 months after the dental implant was placed in ada site 13 in the mouth, the implant had not achieved osseointegration in type iii bone.Primary stability was achieved.The product will be forwarded to the manufacturer for investigation.There were no reported complications.
Additional Manufacturer Narrative
Exemption number: e2015015.After the evaluation was noticed that the item received is different from the item reported.Therefore, the lot number was not considered.
Event or Problem Description
The clinician reported that nearly 5 months after the dental implant was placed in (b)(6) site 13 in the mouth, the implant had not achieved osseointegration in type iii bone.Primary stability was achieved.The product will be forwarded to the manufacturer for investigation.There were no reported complications.(b)(4).
Additional Manufacturer Narrative
Exemption number: e2015015.After the evaluation was noticed that the item received is different from the item reported.Therefore, the lot number was not considered.
Event or Problem Description
The clinician reported that nearly 5 months after the dental implant was placed in ada site 13 in the mouth, the implant had not achieved osseointegration in type iii bone.Primary stability was achieved.The product will be forwarded to the manufacturer for investigation.There were no reported complications.(b)(4).

• Brand Name: EXTERNAL HEX ZYGOMATIC IMPLANT 45.0
• 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: 7518664
• Report Number: 3008261720-2018-02241
• Device Sequence Number: 11076360
• Product Code: DZE
• UDI-Device Identifier: 07898237567327
• UDI-Public: 07898237567327
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K141777
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2018
• Report Date (Section F): 04/24/2018

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: 10/27/2020
• Device Catalogue Number: 109.452
• Device Lot Number: 77429
• Other Device ID Number: 07898237567327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/09/2018
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 07/10/2018; 07/10/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/29/2018; 11/09/2018
• 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