MAUDE Adverse Event Report: JJGC S.A. CM ZYGOMATIC IMPL TI 52.5; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.528
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Fibrosis (3167)
Date of Event	10/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 11.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2020 in ada 11.On (b)(6) 2020, non-osseointegration was verified.Patient presented with bone type iii, poor oral hygiene and inadequate bone quality/quantity.The device was forwarded to the manufacturer.At the event the patient experienced: pain and mobility.No further patient complications were reported.

• Brand Name: CM ZYGOMATIC IMPL TI 52.5
• Common Device Name: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• MDR Report Key: 11004787
• Report Number: 0001222315-2020-16398
• Device Sequence Number: 19974130
• Product Code: DZE
• UDI-Device Identifier: 07898237567822
• UDI-Public: 07898237567822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141777
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021
• Report Date (Section F): 11/19/2020

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: 02/05/2020
• Device Model Number: 109.528
• Device Catalogue Number: 109.528
• Device Lot Number: 800184269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2021
• Device Age: 68 MO
• Event Location: Other
• Date Report to Manufacturer: 11/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 09/13/2021
• 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: 70 YR