MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC 2.5MMD HEX TOOL - SHORT; DENTAL IMPLANT

Model Number HT2.5S

Device Problem Device-Device Incompatibility (2919)

Patient Problems Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Type  Injury  

Event Description

Drivers stuck to implant and required so much force to disengage that it removed implant & couldn't be engaged again.Implant was removed and a second surgery was required.This is a reportable serious injury.

• Brand Name: 2.5MMD HEX TOOL - SHORT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 e hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: lia meshwork ; 3050 e hillcrest dr.; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7474594
• MDR Text Key: 106950867
• Report Number: 3001617766-2018-00082
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307119708
• UDI-Public: 10841307119708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/30/2018

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?: No
• Device Operator: Dentist
• Device Model Number: HT2.5S
• Device Catalogue Number: HT2.5S
• Device Lot Number: 109592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2017
• 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 Age: 69 YR