MAUDE Adverse Event Report: NEODENT - JJGC S.A. CM DRIVE IMPL TI 5.0X16; ENDOSSEOUS DENTAL IMPLANT

Catalog Number	109.687
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Tissue Damage (2104)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number: e2015015.
Event or Problem Description
The clinician reported that 3 months after the dental implant was placed in ada site 29 in the mouth, the implant had not yet achieved osseointegration in type iii bone.Clinician reports pain and peri- implantitis.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.
Additional Manufacturer Narrative
Exemption number: e2015015.Considering the surgical methodology, it was seen that the dentist has used more drills than recommended to perform the implant installation.
Event or Problem Description
The clinician reported that 3 months after the dental implant was placed in (b)(6) site 29 in the mouth, the implant had not yet achieved osseointegration in type iii bone.Clinician reports pain and peri- implantitis.The product will be forwarded to the manufacturer for investigation.There were no reported post-operative complications.(b)(4).

• Brand Name: CM DRIVE IMPL TI 5.0X16
• 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: 7574675
• Report Number: 3008261720-2018-02491
• Device Sequence Number: 1698708
• Product Code: DZE
• UDI-Device Identifier: 07898237569253
• UDI-Public: 07898237569253
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018
• Report Date (Section F): 05/09/2018

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: 12/06/2019
• Device Catalogue Number: 109.687
• Device Lot Number: 800167173G
• Other Device ID Number: 07898237569253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2018
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRAFT; GRAFT; GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR