MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC TORQUE WRENCH MULTI-SETTING; DENTAL IMPLANT

Model Number TWM

Device Problem Defective Component (2292)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Type  malfunction  

Event Description

Per complaint (b)(4), deformation took place as torque wrench could not fix the implant.

Manufacturer Narrative

"updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type, and sections d9, h1,h2, h3, and h6 to report that the device was not received for analysis.Patient information not applicable.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412".

• Brand Name: TORQUE WRENCH MULTI-SETTING
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9502327
• MDR Text Key: 172188655
• Report Number: 3001617766-2019-05982
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119265
• UDI-Public: 10841307119265
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: TWM
• Device Catalogue Number: TWM
• Device Lot Number: 117833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention