MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 3 IMPLANT; DENTAL IMPLANT

Catalog Number 854710

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); Nerve Damage (1979)

Event Date 07/02/2018

Event Type  Injury  

Event Description

Per complaint (b)(4), a patient experienced paresthesia four days after dental implant.It was reported that the patient was at risk for osteomyelitis.The implant was explanted on (b)(6) 2018.

• Brand Name: LEGACY 3 IMPLANT
• Type of Device: DENTAL IMPLANT
• 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: 7768017
• MDR Text Key: 116594049
• Report Number: 3001617766-2018-00183
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101192
• UDI-Public: 10841307101192
• 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,user faci
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/08/2018

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: Health Professional
• Device Expiration Date: 04/24/2023
• Device Catalogue Number: 854710
• Device Lot Number: 113346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2018
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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: 50 YR