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

Catalog Number 854210

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Failure of Implant (1924)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Implant and explant dates are not applicable as device was not placed.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within (b)(4).

Event Description

Per (b)(4), during clinical procedure, observed that implant was too big.

• 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: douglas wilkin ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 6614818356
• MDR Report Key: 10725527
• MDR Text Key: 212686614
• Report Number: 3001617766-2020-07467
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102113
• UDI-Public: 10841307102113
• 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: 10/22/2020

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 Catalogue Number: 854210
• Device Lot Number: 147663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2019
• 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: 83 YR