MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD RS SCREW FIXTURE MOUNT

Model Number GS0029

Device Problems Device-Device Incompatibility (2919); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

It was reported that the doctor experienced some difficulty engaging and disengaging the dental implant while using the screw fixture mount.Despite 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.

Event Description

Malfunction of driver.

• Brand Name: RS SCREW FIXTURE MOUNT
• Type of Device: RS SCREW FIXTURE MOUNT
• 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: 18875208
• MDR Text Key: 337328406
• Report Number: 3007518363-2024-31126
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/21/2023

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
• Device Operator: Health Professional
• Device Model Number: GS0029
• Device Catalogue Number: GS0029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention