MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD RS HEX HANDPIECE ADAPTER MEDIUM

Model Number	RS9026
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of driver.
Additional Manufacturer Narrative
The doctor presented a complaint in malfunction of rs9026 (implant mount) that fractured when conected to dental implant id1333 lot 7858602 at the implantation surgery.The implant was replaced by another similar one.Despite that no patient complications were reported, it could have caused or contributed to a serious injury or require medical or surgical intervention to prevent it.As such, this event is reportable per 21cfr part 803.In the event that new or additional information is received from the investigation of the items, a follow-up report will be sent.Manufacturer's trend analysis show that malfunction of drivers is a low-rate adverse event.

• Brand Name: RS HEX HANDPIECE ADAPTER MEDIUM
• Common Device Name: RS HEX HANDPIECE ADAPTER MEDIUM
• 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: 21581490
• Report Number: 3007518363-2025-00051
• Device Sequence Number: 9276083
• Product Code: DZN
• UDI-Device Identifier: 07290105156853
• UDI-Public: 07290105156853
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: RS9026
• Device Catalogue Number: RS9026
• Device Lot Number: 7856901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female