MAUDE Adverse Event Report: ADIN DENTAL IMPLANT SYSTEMS LTD UNIFIT STAR TORQUE DRIVER; UNIFIT STAR TORQUE DRIVER-SHORT

Model Number UF0067

Device Problem Separation Failure (2547)

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

Event Type  Injury  

Event Description

Malfunction of driver.

Manufacturer Narrative

The doctor presented a general complaint in malfunction of unifit star torque drivers (uf0066 and uf0067).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.

Event Description

Malfunction of driver.

Manufacturer Narrative

The doctor presented a general complaint in malfunction of unifit star torque drivers (uf0066 and uf0067).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: UNIFIT STAR TORQUE DRIVER
• Type of Device: UNIFIT STAR TORQUE DRIVER-SHORT
• 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: 18894855
• MDR Text Key: 337556762
• Report Number: 3007518363-2024-00180
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UF0067
• Device Catalogue Number: UF0067
• Device Lot Number: 7757401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2023
• 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