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

Catalog Number 853710

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Failure of Implant (1924)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

Implant date was not provided.When the requested information becomes available, a supplementary report will be submitted.Lot information is unknown.If additional 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.

Event Description

Per (b)(4), during clinical procedure, cover screw would not engage with implant.

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.

• 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
• MDR Report Key: 11366153
• MDR Text Key: 233085058
• Report Number: 3001617766-2021-01431
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307102052
• UDI-Public: 10841307102052
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 853710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 68