MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY2 IMPLANT 5.2MMD X 16MMD; DENTAL IMPLANT

Model Number 835216

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 12/27/2017

Event Type  Injury  

Event Description

Per complaint no.(b)(4), legacy 2 implant 5.2mm was too large and fractured the buccal plate during a procedure.Implant was removed the same day.This was likely caused by an undersized osteotomy or incorrect sized implant.

• Brand Name: LEGACY2 IMPLANT 5.2MMD X 16MMD
• 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: crystal barczi ; 3050 e hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 7351464
• MDR Text Key: 102839240
• Report Number: 3001617766-2018-00049
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101864
• UDI-Public: 10841307101864
• 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: 03/19/2017

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 Expiration Date: 12/10/2019
• Device Model Number: 835216
• Device Catalogue Number: 835216
• Device Lot Number: 58710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: 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: 48 YR