MAUDE Adverse Event Report: JJGC S.A. SELF-DRILLING ANCHORAGE IMPL MB TI 1.6X7; ENDOSSEOUS DENTAL IMPLANT

Catalog Number 109.496

Device Problem Failure to Osseointegrate (1863)

Patient Problems Inflammation (1932); Fibrosis (3167)

Event Date 07/13/2023

Event Type  Injury  

Event Description

The clinician reports the implant was inserted (b)(6) 2023 in ada 3.On (b)(6) 2023, non-osseointegration was verified.No product was returned to the manufacturer.At the event the patient experienced: mobility and inflammation.No further patient complications were reported.

Manufacturer Narrative

The batch number could be verified.Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed.  the non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants.Most implant failures occur before occlusal loading (analainen et al.2009).Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al.2008).Implants may have to be removed in case one or more of the implant success criteria are not met.Implant success criteria according to buser et al.(1991) are: 1.Absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia 2.Absence of a recurrent peri-implant infection with suppuration 3.Absence of implant mobility 4.Absence of a continuous radiolucency around the implant.The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.

• Brand Name: SELF-DRILLING ANCHORAGE IMPL MB TI 1.6X7
• Type of Device: ENDOSSEOUS DENTAL IMPLANT
• Manufacturer (Section D): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer (Section G): JJGC S.A.; av. juscelino kubitschek de; oliveira, 3291 cic; curitiba PR 81270 -200; BR 81270-200
• Manufacturer Contact: jennifer jackson ; 60 minuteman road; andover, MA 01810 ; 9787472509
• MDR Report Key: 17769114
• MDR Text Key: 323658238
• Report Number: 3008261720-2023-019622
• Device Sequence Number: 1
• Product Code: OAT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109.496
• Device Lot Number: CZM37
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2023
• Event Location: Other
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male