MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG S DENTAL IMPLANT

Model Number	ISPS1035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor reported that the implant was removed due to fracture.No further patient complications were reported.The implant was returned to manufacturer for evaluation.In the event that new or additional information is received from the investigation of the item, a follow-up report will be sent.Manufacturer's trend analysis show that implant fracture is a low-rate adverse event, which is common for endosseus dental implants in clinical use.
Event or Problem Description
Dental implant failure.
Event or Problem Description
Dental implant failure.

• Brand Name: TOUAREG S 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: 17894161
• Report Number: 3007518363-2023-02128
• Device Sequence Number: 11385718
• Product Code: DZE
• UDI-Device Identifier: 07290105151803
• UDI-Public: 07290105151803
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 08/20/2023

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: ISPS1035
• Device Catalogue Number: ISPS1035
• Device Lot Number: 7413724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2023
• Supplement Date Received by Manufacturer: 08/20/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 09/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female