MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 4 IMPLANT; DENTAL IMPLANT

Model Number 874711

Device Problem Device-Device Incompatibility (2919)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Date 03/28/2018

Event Type  Injury  

Event Description

According to the complaint, hex drivers stuck to implant during a procedure and required so much force to disengage that it removed implant, couldn't be engaged again.This is a reportable serious injury.

• Brand Name: LEGACY 4 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: lia meshwork ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7538737
• MDR Text Key: 109070718
• Report Number: 3001617766-2018-00132
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102984
• UDI-Public: 10841307102984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 874711
• Device Catalogue Number: 874711
• Device Lot Number: 109033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR