MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM ZYGOMATIC IMPLANT 35.0; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.523
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
Event or Problem Description
(b)(4).The dentist reported that 8 months after dental implant was installed in intraoral region 14#, its non-osseointegration was observed.In addition, the patient presented bone type iv, 40ncm of primary stability was achieved and immediate load was performed.

• Brand Name: CM ZYGOMATIC IMPLANT 35.0
• 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: 7400238
• Report Number: 3008261720-2018-01621
• Device Sequence Number: 13820622
• Product Code: DZE
• UDI-Device Identifier: 07898237567778
• UDI-Public: 07898237567778
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K141777
• 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): 04/05/2018
• Report Date (Section F): 03/15/2018

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: Dentist
• Device Expiration Date: 12/13/2020
• Device Catalogue Number: 109.523
• Device Lot Number: 83884
• Other Device ID Number: 07898237567778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2018
• Device Age: 24 MO
• Event Location: Other
• Date Report to Manufacturer: 03/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/05/2018
• 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
• Patient Age: 49 YR
• Patient Weight: 100