MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT

Catalog Number 824711

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

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

Per complaint (b)(4), patient experienced lack of primary stability.

Manufacturer Narrative

Follow-up submitted to report device evaluation.

• Brand Name: LEGACY 2 IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9127960
• MDR Text Key: 160317037
• Report Number: 3001617766-2019-03987
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101383
• UDI-Public: 10841307101383
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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: 09/23/2023
• Device Catalogue Number: 824711
• Device Lot Number: 124199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention