MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG¿-OS DENTAL IMPLANT

Model Number	ISF1042
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was returned to manufacturer for evaluation, no fracture was found on item.Manufacturer's trend analysis show that implant fracture and failure are low-rate adverse events, which are common for endosseous dental implants in clinical use.There are several factors that could not be verified that directly affect implant success, including oral hygiene, bruxism or large occlusal forces, superstructure design, implant localization, and bone resorption around the implant.
Event or Problem Description
The clinician reports implant fracture.No further patient complications were reported.

• Brand Name: TOUAREG¿-OS DENTAL IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ADIN DENTAL IMPLANT SYSTEMS LTD; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer (Section G): ADIN DENTAL IMPLANT SYSTEMS LTD.; industrial zone alon tavor; pob 1128; afula, 18111 01; IS 1811101
• Manufacturer Contact: ilana lutvak ; industrial zone alon tavor; pob 1128; afula, ; IS
• MDR Report Key: 16792778
• Report Number: 3007518363-2022-01751
• Device Sequence Number: 20257528
• Product Code: DZE
• UDI-Device Identifier: 07290105151377
• UDI-Public: 7290105151377
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K081751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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 Expiration Date: 11/01/2025
• Device Model Number: ISF1042
• Device Catalogue Number: ISF1042
• Device Lot Number: 7565266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 04/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown