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

Model Number	TWM
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
Per complaint (b)(4), deformation took place as torque wrench could not fix the implant.
Additional 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
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9502327
• Report Number: 3001617766-2019-05982
• Device Sequence Number: 16885871
• Product Code: NDP
• UDI-Device Identifier: 10841307119265
• UDI-Public: 10841307119265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention