MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC HEX TOOL; DENTAL IMPLANT

Catalog Number HT1.25

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 08/15/2022

Event Type  Injury  

Event Description

Per complaint (b)(4), during clinical procedure, deformation was observed.

Manufacturer Narrative

Other relevant history, including preexisting medical conditions and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient identifier, age, weight are unknown.Lot information unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

• Brand Name: HEX TOOL
• 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: 15355350
• MDR Text Key: 299279554
• Report Number: 3001617766-2022-04485
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119609
• UDI-Public: 10841307119609
• 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: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HT1.25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• 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