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

Catalog Number HT2.5

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Per complaint (b)(4), the insertion instrument became wedged with the implant system during the operation.When the implant became released, the bone lamella walls were damaged.Osteopenia was also reported.The implant was extracted.

• Brand Name: HEX TOOL
• Type of Device: HEX TOOL
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: monica roche ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 8545548
• MDR Text Key: 142940931
• Report Number: 3001617766-2019-00178
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119630
• UDI-Public: 10841307119630
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HT2.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention