MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC 30NCM TORQUE WRENCH; DENTAL IMPLANT

Catalog Number TW30

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Other relevant history, including preexisting medical conditions were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient identifier, age, weight are unknown.Implant date and explant date are not applicable since the product was never placed and not removed.Lot information unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), during clincial procedure, torque wrench is not working correctly.

• Brand Name: 30NCM TORQUE WRENCH
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: marcos gutierrez ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443315
• MDR Report Key: 15536461
• MDR Text Key: 301097970
• Report Number: 3001617766-2022-04886
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119241
• UDI-Public: 10841307119241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TW30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male