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

Catalog Number 854210

Device Problems Break (1069); Separation Failure (2547)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

Event Type  malfunction  

Event Description

Per complaint (b)(4), implant components were not separated due to possible damage in screw.

• 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: adrienne stott ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443300
• MDR Report Key: 9165077
• MDR Text Key: 161511005
• Report Number: 3001617766-2019-04444
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102113
• UDI-Public: 10841307102113
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2022
• Device Catalogue Number: 854210
• Device Lot Number: 93277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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: 59 YR