MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD TOUAREG-OS DENTAL IMPLANT 4.2D 11.5L

Model Number	ISF1142
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Dental implant failure.
Additional Manufacturer Narrative
The doctor reported that the implant was removed due to fracture of driver tip (rs9026 lot 7655314) in the hex, during placement.No further patient complications were reported.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 failure due to fracture of tools is a low-rate adverse event.

• Brand Name: TOUAREG-OS DENTAL IMPLANT 4.2D 11.5L
• Common Device Name: TOUAREG-OS DENTAL IMPLANT 4.2D 11.5L
• 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: 20405614
• Report Number: 3007518363-2024-02572
• Device Sequence Number: 12398589
• Product Code: DZE
• UDI-Device Identifier: 07290105151421
• UDI-Public: 07290105151421
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/09/2024

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: ISF1142
• Device Catalogue Number: ISF1142
• Device Lot Number: 7768513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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: Unknown