MAUDE Adverse Event Report: JJGC S.A. TI ALVIM IMPL TI 4.3X13; ENDOSSEOUS DENTAL IMPLANT

Model Number	109.322
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Tissue Damage (2104); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The batch number could not be verified due to incomplete or missing information and / or product from the customer.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 loss of an endosseous dental implant after successful osseointegration and restoration is a known inherent risk of the procedure.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: absence of persistent subjective complaints such as pain, foreign body sensation and /or dysesthesia.Absence of a recurrent peri-implant infection with suppuration.Absence of implant mobility.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.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2018 in fdi 43.Details of surgery: immediate extraction site.On (b)(6) 2020, loss of osseointegration was verified.No product was returned to the manufacturer.There were no patient operative or post-operative complications reported.
Event or Problem Description
The clinician reports the implant was inserted (b)(6) 2018 in fdi 43.Details of surgery: immediate extraction site.On (b)(6) 2020, loss of osseointegration was verified.No product was returned to the manufacturer.There were no patient operative or post-operative complications reported.
Additional Manufacturer Narrative
The batch number could not be verified due to incomplete or missing information and / or product from the customer.Our manufacturing q-system assures that production and process controls are in place to ensure that batches confirm to the applicable specifications before they're distributed.The loss of an endosseous dental implant after successful osseointegration and restoration is a known inherent risk of the procedure.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: TI ALVIM IMPL TI 4.3X13
• 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: 10509739
• Report Number: 3008261720-2020-04205
• Device Sequence Number: 2670583
• Product Code: DZE
• UDI-Device Identifier: 07898237567075
• UDI-Public: 07898237567075
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101207
• Summary Report (Y/N): Y
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Model Number: 109.322
• Device Catalogue Number: 109.322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/12/2021
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: 66 YR