MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD RS STRAIGHT TRANS MUCOSAL ABUTMENT 1MM

Model Number	RS3731
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The doctor reported fracture of abutment screw.No further patient complications were reported.Manufacturer's trend analysis show that abutment screw fracture is a low-rate adverse event, which is common for endosseus dental implants in clinical use.
Event or Problem Description
Abutment screw fracture.

• Brand Name: RS STRAIGHT TRANS MUCOSAL ABUTMENT 1MM
• Common Device Name: RS STRAIGHT TRANS MUCOSAL ABUTMENT 1MM
• 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: 23740205
• Report Number: 3007518363-2025-05191
• Device Sequence Number: 18694315
• Product Code: NHA
• UDI-Device Identifier: 07290105155375
• UDI-Public: 07290105155375
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K081751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/07/2025

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: RS3731
• Device Catalogue Number: RS3731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/08/2025
• 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 Age: 65 YR
• Patient Sex: Male