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

Catalog Number 823713

Device Problems Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.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 deviation 1412.

Event Description

Per complaint (b)(4), after clinical procedure patient experienced loss or failure of implant to osseointegrate.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation (b)(4).

• 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: 10539587
• MDR Text Key: 207116411
• Report Number: 3001617766-2020-06370
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307101277
• UDI-Public: 10841307101277
• Combination Product (y/n): N
• PMA/PMN Number: K192221
• 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: 12/15/2020

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: 823713
• Device Lot Number: 143407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR